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RedHill Biopharma's (RDHL) CEO Dror Ben-Asher on Q3 2021 Earnings Call Transcript
Nov. 30, 2021 4:09 PM ETRedHill Biopharma Ltd. (RDHL), REDIF1 Comment
Q3: 2021-11-30 Earnings Summary
EPS of -$0.05 beats by $0.23 | Revenue of $21.61M (3.18% Y/Y) misses by $1.79M
RedHill Biopharma Ltd. (NASDAQ:RDHL) Q3 2021 Earnings Conference Call November 30, 2021 8:30 AM ET
Company Participants
Alexandra Okmian - Senior Business Development and IR Manager
Dror Ben-Asher - CEO
Guy Goldberg - Chief Business Officer
Gilead Raday - COO
Rob Jackson - SVP, Sales and Marketing
Micha Ben-Chorin - CFO
Bob Gilkin - SVP, Market Access and Trade Relations
Conference Call Participants
Brandon Folkes - Cantor Fitzgerald
Boobalan Pachaiyappan - H.C. Wainwright
David Hoang - SMBC
Robert Hazlett - BTIG
Scott Henry - ROTH Capital
Operator
Good day and thank you for standing by. Welcome to the RedHill Biopharma's Third Quarter 2021 Results Financial Conference Call. [Operator Instructions]
At this time, I would like to introduce to the conference call RedHill's CEO, Dror Ben-Asher; Micha Ben-Chorin, Chief Financial Officer; Gilead Raday, Chief Operating Officer; Guy Goldberg, Chief Business Officer; Adi Frish, Chief Corporate and Business Development Officer; Rob Jackson, Senior Vice President, Sales and Marketing; Bob Gilkin, Senior VP, Market Access and Trade Relations; and Dr. June Almenoff, Chief Medical Officer.
Before we begin, we will read from the RedHill's Safe Harbor statement. Please go ahead.
Alexandra Okmian
Thank you, Brian. This conference call may contain projections or other forward-looking statements regarding future events or the future performance of RedHill, including statements with respect to the business promotion and other efforts related to RedHill's commercialization activities and the initiation, timing, progress and results of RedHill's research, manufacturing, preclinical studies, clinical trials, marketing applications and approvals, if any, including the clinical trials of opaganib and RHB-107 for the treatment of COVID-19.
These statements are only predictions and RedHill cannot guarantee that they will, in fact, occur. RedHill does not assume any obligation to update that information. Actual events, performance, timing, results, or commercialization activities may differ materially from what RedHill projects today.
Additional information concerning factors that could cause actual events, performance, timing, results, or commercialization activities to materially differ from those contained in the forward-looking statements can be found in the company's annual report on Form 20-F filed with the SEC on March 18th, 2021 and in its other filings with the Securities and Exchange Commission.
Dror Ben-Asher
Thank you, Alexandra. Good day everyone and thank you for joining our third quarter earnings call. Today, we'll be presenting detailed R&D, commercial, and financial highlights.
In light of the recent emergence of the Omicron variant and the risk presented by future variants of concern, we will elaborate on RedHill's strategy with opaganib and RHB-107 and our increasingly irrelevant mechanisms of action potential against the emerging variants.
Our U.S. commercial business continues to drive growth, reiterating a second consecutive quarter in net revenue record of $21.6 million despite continuously challenging pandemic environments.
Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform, adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. Rob Jackson, who is heading out Marketing and Sales will further elaborate shortly.
Turning to R&D, given the recent emergence of the heavily mutated Omicron or South African variant, as well as likely emergence of other variants of concern over time, the importance of drug candidates that are independently of the viral spike protein is growing.
This makes both opaganib and RHB-107 host targeted mechanism of action and expected maintenance of effects against new variants, increasingly more relevant in the battle against COVID-19.
The third quarter saw significant focus on completing opaganib's global Phase 2/3 COVID-19 study in hospitalized patients. Specifically in the currently underserved hospitalized moderately severe patient group, which the Pfizer and Merck do not address.
A sub-population comprising more than 50% of our total study population, opaganib demonstrated a 62% reduction in mortality, as well as improved return to room air and area hospital discharge.
This is consistent with what we have seen in our Phase 2 study and compassionate use experience. The consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population.
We have now provided regulators in various countries with robust data packages to facilitate discussions on next steps and we'll continue to provide data to regulators in additional countries.
Expedited review of the opaganib data has already been granted by EMA, the European Union's regulatory body equivalent to the FDA in United States. In parallel lance, we continue to progress our Phase 2/3 program in non-hospitalized patients in the United States and South Africa, with our other novel once-daily oral COVID-19 drug candidate RHB-107. We passed a topline results expected in the first quarter of 2022. Gilead, our Chief Operating Officer will elaborate about the status of our COVID-19 programs shortly.
Our Phase 3 study of RHB-204 in pulmonary NTM disease continues to enroll patients in the United States. Importantly, progress with Phase 3 stage RHB-104 for Crohn's disease is expected to speed up, thanks to a recent much awaited potential progress in Mycobacterium avium subspecies paratuberculosis or in short, MAP detection research. We're very excited about that.
With steep reduction in quarterly operating and net loss, a quarterly record gross profit of $12.4 million with improved gross margin from net revenues and a potential commercial non-GAAP EBITDA breakeven before the end of the year, along with advanced, exciting, and timely R&D pipeline, we are well-positioned for short, medium, and long-term success as an emerging specialty pharma company.
Before turning to our Chief Business Officer, Guy Goldberg and the rest of the team for our presentation, please remember to press the link in order to view our detailed slides to be followed by a Q&A session.
Guy Goldberg
Thank you, Dror. As we near the end of the year, RedHill is at a very important point. I will start with the bottom of the side, focusing on RedHill's pandemic program with Omicron and the potential for future variants dominating the attention of public health officials, what they have been saying loud and clear is that a simple, scalable, effective, and safe therapeutic is desperately needed.
As we all know, the hope that vaccines alone will get us out of this pandemic will most likely not become reality. RedHill is uniquely positioned to make a difference with its two oral COVID vaccine -- sorry two oral COVID therapeutic candidates.
First, opaganib, our novel orally administered first-in-class SK2 inhibitor addressing the moderately severe in-patient hospitalized population. With its method of action targeting the host cell rather than working on the virus directly, which we believe we can cast a wider that of efficacy against emerging variants such as the Omicron variant.
We have conducted two clinical studies, a Phase 2 and a Phase 2b study in hospitalized COVID patients, both demonstrating the potential of opaganib and Gilead will provide more detail of the Phase2/3 study that is the focus of our submissions in several countries around the world.
These submissions open up a potentially milestone-rich upcoming few months as we get feedback from these regulatory agencies as far as next steps. Gilead will also provide important new updates later in the presentation of the timelines for regulatory feedback as well as new biomarker data and support that are post-hoc analysis as identified the correct target population for opaganib.
Second, we have RHB-107 or upamostat, an orally-administered inhibitor, a best one family of trypsin-like serine protease, being developed as a treatment for non-hospitalized COVID patients.
upamostat has demonstrated protein inhibition of SARS-CoV-2 viral replication in preclinical model of human bronchial tissue. And there's -- as a result of prior development in a number of indications in several clinical studies, we also have a critical safety profile from approximately 200 patients. We are conducting a Phase 2/3 study non-hospitalized COVID-19 patients in the U.S. and South Africa and we have completed recruitment for Part A of the study and expect topline results in Q1 2022.
Importantly, RHB-107 is also a once-daily oral pill and is also host mediated, which means that it should also potentially work against various mutations, such as Omicron. Also importantly patients in the study are tested for specific viral strain.
Returning down to the top part of the slide in our financial highlights from Q3. On the commercial side, we generated record quarterly revenues despite industry-wide challenges that we believe we will see growth throughout the end of the year and into next year.
As a small company, we continue to stand the test of the pandemic and prove we are a resilient organization. To this, we generated 50% quarter-over-quarter growth, commercial coverage continues to improve, and we continue to achieve important launch milestones that will be covered later in the presentation.
We believe Talicia has enormous potential both for patients and as a value driver for RedHill as a company. As with almost all launches, especially during these challenging times, we continue to advise that it takes time to build awareness and acceptance both with payers and also exhibitions.
With Movantik, we continue to maintain our market leader position. Movantik is well-liked by physicians that it's great reimbursement, great efficacy and safety, and great brand recognition satisfaction. There's still a very large and underserved OIC patient population and RedHill continues to improve of Movantik's status of best unrestricted coverage in the PAMORA class.
Finally, we've maintained a cash position of $51.5 million as of September 30th to support our R&D and commercial efforts.
I would like to provide a brief overview of RedHill to those new to the story who may be on our call today. RedHill is a fully integrated specialty biopharmaceutical company focused on gastrointestinal and infectious diseases, with a robust pipeline of drugs and a world-class commercial operation right out of our headquarters, U.S. headquarters in Raleigh, North Carolina.
At the top of this slide, you see the three FDA approved drugs we promote, Movantik for opioid-induced constipation; Talicia for H. pylori infection; and Aemcolo for travelers' diarrhea caused by non-invasive strains of E. coli. Rob Jackson, our Senior VP for Marketing and Sales will be going into detail of the commercial efforts.
The second part of the slide shows the multiple late-stage programs in development addressing important unmet medical needs. Gilead Raday, our Chief Operating Officer will review our two COVID programs that I just mentioned. I will then provide an update on RHB-204 two for NTM disease and RHB-104 for Crohn's disease.
I will now turn it over to Gilead.
Gilead Raday
Thank you, Guy. In the following slides, I will provide an overview of our advanced COVID-19 programs, specifically with respect to the promise for addressing the Omicron variant and the growing concerns due to potential emergence of resistance to current vaccines and antibodies. I will also provide further data and analyses from the global Phase 2/3 study, some of which has not been shared before, which bolster our previous reporting of an apparent meaningful benefit of opaganib to the survival of moderately severe hospitalized COVID-19 patient.
As a reminder, opaganib is an oral pill, which is a first-in-class proprietary selective sphingosine kinase-2 inhibitor. Through inhibiting this host factor enzyme, opaganib exerts a dual action against COVID-19, inhibiting viral replication on the one hand and reducing the body's excess immune response to the infection on the other hand.
Preclinical efficacy has been demonstrated in numerous anti-inflammatory and anti-viral models, including demonstrating the blocking of SARS CoV-2 viral replication across several variants in human bronchial tissue.
Multiple Phase 2 studies and compassionate use in COVID and non-COVID indications have shown promising signals of activity and safety in hospitalized patients.
The recently completed global Phase 2/3 study in COVID-19 show opaganib's apparent benefit to the survival of hospitalized COVID-19 patients in moderately severe condition. These are patients with COVID-19 pneumonia, who require supplemental oxygen of up to 60% fraction of inspired oxygen, or FIO2 in short.
These patients represent a large underserved COVID-19 patient population, which the Pfizer and Merck pills do not address. The hospitalized patient population that opaganib benefited in the study was far more advanced in disease progression than the early stage outpatients which participated in the Pfizer and Merck studies.
opaganib benefited a population of hospitalized patients in moderately severe condition, with a median of 11 days from the onset of symptoms. While the Pfizer and Merck studies were limited to outpatients with a maximum duration of five days from onset of symptoms.
This distinguishes opaganib as a potential game changer for advanced COVID-19 patients who has a high risk of dying from the condition and are already well beyond the realm that the Pfizer and Merck pills can target.
Importantly, opaganib's mechanism of action is independent of the Omicron variant spike protein mutations, which are raising global concerns regarding its potential to evade vaccines and antibodies.
opaganib's anti-viral effect is on the intracellular process of viral replication. At the replication transcription complex, this takes place downstream from the viral attachment to the cell membrane and viral entry into the cell. As such opaganib's activity which blocks the replication of the virus inside the cells isn't impacted by changes in the viral envelope.
Specifically, changes in the spike protein are of no direct consequence to opaganib's pathway. opaganib's proposed anti-viral activity is hence expected to be fully maintained against the Omicron variant and also against other future foreseeable spike protein variants of concern.
In a similar fashion, opaganib's proposed anti-inflammatory activity is also independent of Omicron variant spike protein mutations. The reduction in inflammation due to opaganib's inhibition of SK-2 is not directly related to the SARS CoV-2 virus, but rather to the body's immune responses. As such opaganib's anti-inflammatory activity is also expected to be fully maintained against the Omicron variant and against other potentially emerging variants of concern.
opaganib's capacity to work against Omicron and other future variants through both its anti-viral and its anti-inflammatory modes of action, position it in a unique and high priority potential COVID-19 therapy potential.
The reason we are excited about opaganib's potential central role in treating COVID-19 is the apparent benefit of opaganib in reducing mortality of advanced hospitalized COVID-19 patients in moderately severe condition, patients requiring a level of oxygen supplementation of up to 60% fraction of inspired oxygen or FIO2.
In our global Phase 2/3 study, this patient population consisting of 251 subjects showed a significant 62% reduction in mortality events when treated with opaganib with a nominal P value of 0.019. The mortality rate in the control arm was 15.7%. indicative of the high risk of such patients dying due to the serious condition they were in.
Treatment of these patients with opaganib reduced the mortality risk to 6%, a very meaningful potential to save lives. The Kaplan Meier curves of time to mortality event in this hospitalized patient population, show a clear separation, beginning from a few days after treatment initiation and carry through to the end of the follow-up period of day 42.
Supporting the critically important benefits of the survival of patients, additional key clinical outcomes showed a consistent benefit of opaganib for this patient population. 76.9% of opaganib-treated patients were weaned from their oxygen support, and were able to breathe room air by day 14 versus 63.4% of placebo, an efficacy benefit, with nominal P value of 0.033.
Consistent with these findings, other key secondary endpoints also showed an apparent benefit of opaganib in this hospitalized patient population with nominally significant P value. A clinical improvement of two or more points on the WHO ordinal scale by day 14 showed a meaningful difference with approximately 80% clinical improvements in the opaganib treated arm versus 66% in the control arm with nominal P value of 0.023.
Similarly, the time to clinical improvement, down to a score of three or lower from a baseline score of five on the WHO ordinal scale was shorter for patients treated with opaganib with a median of eight days versus 10 days and a P value of 0.01.
Patients treated with opaganib were also discharged earlier from hospital with a mean difference of approximately four and a half fewer days in hospital with a nominal P value of 0.022.
The consistency of opaganib's benefits across the various clinical outcomes evaluated strengthens the inference the clinical benefit is not a one-off statistical finding as the result of a specific measurement.
Further supporting the apparent overall benefits of survival, opaganib's benefits in this population of patients was consistent across the territories participating in the study, in Europe, Latin America, Israel, and Russia, demonstrating that the survival benefit was not driven by any territorial outliers.
To ensure that the clinical benefits is not a result of potentially confounding risk factors, a comprehensive analysis of the potential confounders was conducted. As can be seen, an exhaustive list of such potential confounders was analyzed. This analysis demonstrated clearly that the survival benefit remains consistent and high within a range of 59% to 66% survival benefit, irrespective of potentially confounding risk factors, including such major known factors, such as age, sex, diabetes, BMI, or use of dexamethasone as underlying standard of care.
In recent analysis of the inflammatory biomarkers of the opaganib study subjects, which we are sharing publicly today for the first time, further substantiates and supports the utility of FIO2 is a valuable indicator of COVID-19 disease severity, and also as a potential predictor of a treatment benefit with opaganib in this target population of hospitalized patients.
This table shows that known and accepted disease severity indicating markers such as CRP, lymphocyte counts, and D-Dimer are in close correlation in agreement with FIO2. This demonstrates with very significant nominal P values as shown in the rightmost column. That the group of patients characterized as requiring lower FIO2 at baseline that is up to 60% FIO2, are indeed a distinct group of hospitalized patients exhibiting lower levels of severity markers than those patients that required higher than 60% FIO2 oxygen at baseline.
This recent analysis that was not previously publicly announced further supports the overall framework of the FIO2 based analysis of study outcomes. It supports using FIO2 as an indicator of the severity and as a potential identifier of the patient population that stands the best chance of significantly benefiting from being treated with D-Dimer.
The analysis of safety outcomes shows that safety events in the study were similar between treatment arms, with no new safety concerns emerging. The majority of the TEAEs were mild to moderate in severity. Serious TEAEs were experienced by 52 out of 230 patients in the opaganib arm versus 52 out of 233 patients in the placebo arm similar ratios.
TEAEs with an outcome of death occurred in 15.7% versus 17.2% in the opaganib and placebo arms respectively. The excellent safety results supports the overall risk benefit evaluation of opaganib in this patient population, and is expected to be an important component in regulatory considerations going forward.
Acknowledging that the analysis of the study that demonstrates the apparent benefits for the moderately severe patient population was conducted post-hoc, it is important to clarify why we have a high degree of confidence that this outcome is not a statistical artifact, inferring that opaganib may indeed be effective in this population.
The framework of the post-hoc analysis which identified a subpopulation showing a meaningful benefit when treated with opaganib is strongly supported by the following aspects. FIO2, which is a parameter used to identify population is a clinically and medically relevant parameter for capturing oxygen requirements of patients and for indicating disease severity. This conjecture is now strongly supported by the correlation of FIO2 with known and accepted inflammatory biomarkers of disease severity.
Consistency of opaganib's apparent benefits across the different clinical endpoints strengthens the likelihood that the outcome of any one particular endpoint is not a statistical artifact. The consistency of opaganib's apparent benefit across the study territories provides additional support showing the effect seen or not driven by any particular territorial outlier.
Further, while not shown in this presentation, we also tested the consistency of paganism added benefit using different oxygen supplementation cutoff points, for example, FIO2 of 50% instead of 60%. This analysis confirmed that the benefit for the lower oxygen supplementation patients, which reflects lower severity of patients is maintained irrespective of the precise cutoff point selected, again, reducing the likelihood that the analysis is a statistical artifact and supporting the assertion that there's a correlative relationship between lower severity of disease and opaganib's capacity to benefit the patients.
Finally, as presented earlier, opaganib's apparent benefit is not dependent on baseline risk factors or potential confounders showing that opaganib is the likely factor underlying the differences in outcomes for the treated patient.
Given all this, despite the analysis being post-hoc, the thoroughness of this analysis provides a high degree of confidence that the apparent benefit is not a statistical artifact and opaganib may be safe and effective in this underserved hospitalized COVID-19 patient population.
The resurgence of concerns that Omicron variant might show resistance to vaccines and antibodies further highlights the urgency and the potential advantages of opaganib's potential effectiveness against such variants.
To update on the regulatory status, we have filed opaganib data package in key territories worldwide and continue to file in additional countries. We are anticipating regulatory guidance for next steps in the targeted hospitalized COVID-19 patients population where there is no currently effective treatment.
Europe's EMA has indicated rapid procedure timelines with preliminary feedback expected by year end. Preliminary feedback from the U.S. FDA is expected in January 2022. Additional territories pursued are the U.K., Russia, Brazil, Israel, Switzerland, Colombia, India, and South Africa. We're also making plans for a confirmatory study with opaganib in the targeted moderately severe hospitalized patients.
Subject to regulatory feedback, we will consider shifting from the current standards of our declassifications based on the World Health Organization Ordinal Scale, which utilizes the type of oxygen delivery device to define in COVID-19 pneumonia severity using FIO2 as the key parameter.
Moving over to a quick update on RHB-107 or upamostat, our second COVID-19 novel oral program that is currently being evaluated in a Phase 2/3 study in non-hospitalized COVID-19 patients in the U.S. and in South Africa.
RHB-107 is a once-daily oral capsule given early in the course of the disease to outpatients. It targets serine proteases, which are human enzymes that are involved in facilitating the entry of SARS CoV-2 into target cells. The cleaving of the spike protein by the host human serine proteases is a necessary step in viral attachment and entry into the cells, which is independent of the mutations observed in the Omicron variant that are altering the spike protein antigenic properties.
As such RHB-107 is expected to be insensitive to mutations in spike protein, given its host mediated mechanism of action. RHB-107 has demonstrated inhibition of SARS CoV-2 viral replication in preclinical model of human bronchial tissue and is currently being evaluated in outpatients with symptomatic COVID-19 in the U.S. in South Africa.
Recruitment for part A of the study has been completed and topline readout is expected in Q1 2022. We plan to also analyze variants and we'll plan to include the Omicron variants of concern in the study analysis going forward.
I will now turn it back to Guy Goldberg for reviewing additional R&D programs that are not COVID related.
Guy Goldberg
Thanks Gilead. So, we'll start with RHB-204. RHB-204 is a novel combination therapy of three antibiotic drugs that are active against non-tuberculous mycobacteria infection or NTM disease. We're currently in a Phase 3 study as a first-line therapy. This is important and its value-driving study because NTM is a difficult to treat infection with no FDA approved first-line standard-of-cure treatment. In addition, this is an orphan disease with an estimated 110,000 pulmonary NTM patients in the United States.
RHB-204 has been granted orphan drug designation, qualified infectious disease product designation and Fast-Track designation. With these designations, it is eligible for priority review of the NDA and 12 years of market exclusivity.
This slide shows the study design. We are testing RHB-204 as a potential first-line standalone oral therapy. The randomized placebo controlled Phase 3 study is planned to enroll 125 subjects. The key study endpoints of sputum culture conversion and patient reported critical outcomes will be evaluated but six with longer term follow up including the post treatment benefits of conversion.
An important recent change is that we added an interim sample size we estimate at approximately 50% enrollment. In addition to accelerate recruitment, we're planning to expand the study to additional territories outside the United States, including the U.K. and Japan.
I will now provide an updated RHB-104, our innovative treatment for Crohn's disease. As Dror mentioned, based on recent published research, potential progress in Mycobacterium avium paratuberculosis or MAP, diagnostic technology may enable us to advance the program towards a confirmatory study and Mathcad positive, moderate severe Crohn's patients subject, of course, to required regulatory input.
As a reminder about this program, there is growing evidence that intracellular mycobacteria play a crucial role in Crohn's disease. Investigators have specifically identified MAP as the putative cause of the disease. Testing this theory, we conducted a Phase 3 study in Crohn's disease that successfully met our primary and key secondary endpoints, including remission at 26 weeks, response of week 26, early remission at week 16, durability, maintenance and others. Overall, RHB-104 demonstrated meaningful, consistent, and statistically significant clinical activity.
In addition, the apparent benefit in patients with concomitant anti-TNF use indicates that RHB-104 should potentially be used effectively and safely as an adjunct treatment to other standard-of-care medications.
Since we completed the Phase 3 study, there has been a lot of work by us and others on a companion diagnostic to identify MAP infection. It is not an easy thing to do. However, we believe based on recent public research, that there may be progress and we will have an update for investors as soon as we can validate the method.
If there is a successful diagnostic, we envision conducting an additional confirmatory clinical study with entry criteria being mapped positive status at a primary endpoint, including because of healing. We will of course need FDA feedback however, we envision that such a steady could be relatively small, perhaps 100 to 150 patients.
Crohn's disease is a large multi-billion dollar market with a large unmet medical need due to the limited benefit of monoclonal antibody therapy and other immune-suppressive drugs and safety related issues to those treatments.
I will now turn it over to Rob to walk through our commercial progress.
Rob Jackson
Thank you, Guy and good morning. Over the next few minutes, I'm going to summarize the excellent progress we made during the third quarter in our sales, marketing, and market access activities, so that you can understand how we've developed our business and why we feel increasingly confident about the fourth quarter and 2022.
In the third quarter, RedHill achieved record quarterly prescription volume for Talicia despite the continuously challenging pandemic environment. Talicia prescription volume grew by 117% over Q3 2020 and by 15%, a five-point improvement over the second quarter growth rate of 10%
Simultaneously, we added growth of Movantik over second quarter of 2021. RedHill continues to maintain clear market leadership of the PAMORA class and we are confident in our ability to capitalize on an improving selling environment during the fourth quarter.
In the second quarter, RedHill grew Movantik volume by 5.6% over first quarter of 2021 and we added an additional 1% growth in third quarter. We achieve this by taking a disciplined approach to focusing on the pain segment.
In tandem, we're also executing marketing strategies that focus on growing the PAMORA market. This is a key objective of Movantik as the established market leader. We've invested heavily in digital marketing tactics to first raise opioid-induced constipation awareness with patients and prescribers and secondly, to educate these potential customers about how Movantik can help provide relief from the symptoms of OIC.
During the third quarter, we also achieve significant market access successes with key payers that we believe will yield further growth Movantik during the fourth quarter and 2022.
A key predictor of the health of the OIC market is the growth or decline in the rate of opioid prescribing. As you can see here, opioid prescribing continues to stabilize during 2021, a major improvement over the declining trend that began way back in 2012. There is a very strong correlation between opioid prescribing and Movantik volume and a stable opioid prescribing trend provides support for Movantik in the entire PAMORA class.
On this next slide, you can clearly see the two other things are happening. First, prescribing volume in the PAMORA class is stabilizing, similar to what we're seeing in the opioid class and this is a good sign for Movantik.
Second, we can see a shift in PAMORA prescribing trends with the class beginning to return to growth. This is a significant change for the PAMORA class and on a moving annual total basis, PAMORA prescribing volume bottomed out in June and has remained steady or improved slightly since then. Again, this is a very good sign for Movantik business and reflects our efforts and investments as the market leader to return the PAMORA class to growth.
In summary, Movantik continues to achieve new milestones. Over 2.5 million prescriptions have been dispensed since launch. Overall, Movantik has achieved about 90% coverage across all payers and new prescriptions and total writers both increased year-on-year during third quarter of 2021.
Simultaneously, Talicia continue to achieve new milestones as well and in third quarter, Talicia achieved its best ever performance in terms of prescription volume growth.
Talicia achieved a new high in commercial payer coverage and Talicia also achieved further improvements in customer access, which in turn enabled greater trial and usage of the brand. Given what we have seen so far this quarter, we expect that this trend will accelerate in the fourth quarter.
In the third quarter, Talicia achieved 15% growth and we are optimistic this growth will accelerate as recent payer wins take effect, new payer wins come to fruition and field execution continues to improve.
Any microbial stewardship is an important issue and when the most effective antibiotics are used first line, they provide the best chance for cure, while eliminating the need for second, third, and even fourth lines of treatments. These growing realizations among the prescriber community are enabling Talicia to achieve record performance in third quarter for weekly, monthly, and quarterly volume. And in the fourth quarter, we'll continue to increase our focus on Talicia and inspect to further accelerate our growth heading into 2022.
On the payer front, our market access team has continued to improve our very competitive position with commercial payers. Additionally, Talicia was recently awarded a very significant contract by Medi-Cal, the California State Medicaid program. Effective January 1st, 2022, Talicia will be available to 14 million Medi-Cal beneficiaries as a preferred brand with no restrictions. When all managed Medicaid plans will follow the state contract drug list, we are confident this will accelerate Talicia uptake in what is the second largest individual state in the country for H. pylori infections and treatments. This is another clear sign that prescribers increasingly recognize first, the challenges of clarithromycin resistance that were clearly outlined by the American College of Gastroenterology's 2017 guidelines. And secondly, the pitfalls of continuing to persist with using clarithromycin-based therapy as a first line agent of choice.
I want to reiterate; this brand continues to achieve new milestones. Again, we had record weekly, monthly, and quarterly prescription volume. We expect that that's going to continue into next year and certainly in the fourth quarter, we had our highest levels of commercial and government coverage, and we recently had the unrestricted Medi-Cal when as well. And lastly, we achieved 117% prescription volume growth over third quarter of 2020 with Talicia.
We also continue to promote Aemcolo to consumers, PCPs, and gastroenterologist. The COVID-19 pandemic has obviously had a very negative impact on international travel, especially non-essential travel outside of continental United States, where travelers' diarrhea risk is greatest. Our midterm expectations for Aemcolo are tempered by this reality.
In summary, we finished the third quarter with a consistent in growing trend of Talicia growth. We achieved numerous commercial milestones for Talicia. And as the market leader in the PAMORA class, we demonstrated our ability to continue to grow new Movantik prescriptions, stabilized prescription volume in the PAMORA class, and further improve on our already strong Movantik payer coverage. We're looking forward to further improving our performance in the fourth quarter in 2022.
Thank you for your time and I'll turn the call back to our CFO, Micha Ben-Chorin.
Micha Ben-Chorin
Thank you, Rob. Good morning. Good afternoon. I will provide a short financial summary of the quarter. Revenue is executing on a consistent growth and value creation strategy, enabling us to be near quarterly commercial non-GAAP EBITDA breakeven by the end of this year.
We have achieved another quarterly record of net revenues and gross profits, accompanied by a reduction in operating and net loss. Our cash balance of $51.5 million as of September 30th, 2021 has been supplemented by more than $20 million in equity financing during this month of November.
Net revenues were $21.6 million for the third quarter of 2021, a second consecutive quarter of record net revenues attributable to an increase in revenues from both Talicia and Movantik, as shown by Rob.
The record net revenues also contributed a quarterly record gross profit of $12.4 million, an increase of 14% from previous quarter, which represents 57% gross margin from net revenues compared with 51% in the previous quarter.
On the expenses side, we had substantially lower expenses in the third quarter during the second quarter, $29.8 million compared with $35.8 million, mainly attributable to the completion of our global COVID-19 Phase 2/3 study with opaganib.
Operating loss was approximately $17.4 million compared with $24.9 million in the previous quarter, a decrease of 30%, which was mainly attributable to increase in revenues, increase in gross profit, completion of our -- great majority of our COVID-19 programs, and reduction in share-based compensation expenses.
Net cash used in operating activities was approximately $19 million for the third quarter of 2021, similar to the second quarter of 2021. We've ended the quarter well-positioned for potential quarterly commercial non-GAAP EBITDA breakeven by the end of this year.
I will now turn it over to Dror for Q&A.
Question-and-Answer Session
Operator
Thank you. [Operator Instructions]
And your first question comes from the line of Brandon Folkes from Cantor Fitzgerald. Your line is now open, you may asked your question.
Brandon Folkes
Hi, thanks for taking my questions and congratulations on all the progress in both the pipeline and the commercial front. Maybe just firstly on opaganib, I appreciate all the additional data there. Should we think about the EMA as being the most receptive here and potentially, I know you said we're going to expect feedback from them first, is that indicative of that opaganib is probably going to be in the lead in the EMA versus the U.S.?
Maybe secondly, just staying on the pipeline on 204, you talked about expanding the territories in the Phase 3, is that just to speed up the pace of enrollments and the program or should we think of something else driving the potential expansion there?
And then lastly, if I may just slip in all three up front, on the Talicia coverage, obviously, congratulations, great coverage there. Just going forward, should we expect additional wins here or improvements in coverage? Or do you believe you're in a very strong steady state now and it's really just executing on those coverage points? Thank you.
Dror Ben-Asher
Thank you. Its Dror here. Starting with the question about EMA and whether this is likely to be the most important response in the short-term. So, you're right about saying that this is likely to be first responder as Gilead said before the end of the year. It's an expedited review, which we're very happy about, but it does not necessarily mean that this is the territory where we expect the fastest progress.
We are applying in many more countries, some of them with a very high degree an increasing need for treatment for this patient population in Latin America, in Europe, Israel, Switzerland, India, South Africa, and others and we do not know at this point which country or countries will be the most promising for an advance towards the market.
Your question about RHB-204 for NTM infections, yes, the speed of enrollment is the main reason that we are expanding the study to additional territories. The other reason is that we see strong need for RHB-204 for NTM infections in other countries, such as Japan, where there's actually more patients than in the U.S.
Your last question about Talicia coverage and whether we should be expecting additional coverage further improvement. Right now coverage is excellent, but it can be improved. I refer this to Bob Gilkin who is heading our Market Access team. Bob, would you like to elaborate on the Talicia coverage and what we can expect moving forward?
Bob Gilkin
Sure. Thank you, Dror. Appreciate that. So, first, Rob and I are committed with pulling through the great coverage that we have for Talicia, eight out of 10 commercially insured patients have access Talicia. Most of those patients have access with no restrictions.
We are committed to expanding that coverage. Our national account executive team is working hard diligently. We have of many things in the works right now. I cannot elaborate at this time, but definitely expect to see more wins as we go into 2022.
We're not done yet. If there's any indication of our ability to get it done, take a look at Movantik and what we were able to do once we acquired it from AstraZeneca. Our team is -- has continued to improve coverage and we expect to do the same thing with Talicia. Like I said that Rob and I are committed with pulling our current coverage through with our gritty at TCs out there in the field. Thank you.
Brandon Folkes
Great. Thank you very much. Appreciate all the detail.
Operator
Thank you. We will now be taking our next question that comes from the line of Ram Selvaraju from H.C. Wainwright. Your line is now open, you may ask your question.
Boobalan Pachaiyappan
This is Boobalan dialing in for Ram Selvaraju. Can you hear me okay?
Dror Ben-Asher
Yes, we can.
Boobalan Pachaiyappan
All right. Awesome, great. Great presentation, congrats on your progress. Just a few questions from our end. So, your Phase 2b post-hoc analysis looks solid and convincing. So, with respect to using FIO2 as a medical irrelevant parameter, so just curious, have you spoken to KOL and received any preliminary thoughts regarding its feasibility in current medical practice? Also, are there any limitations that you're aware of in using FIO2 as a relevant parameter in treating COVID patients?
Dror Ben-Asher
Thank you. Certainly we have interacted with KOLs and we will have further interaction as we indicated with regulators This is a change from what the standard World Health Organization Ordinal Scale characterizes a severity, but certainly FIO2 is a very well-known measure and parameter that is being used by the treating physicians and KOLs and we get feedback that is certainly a feasible parameter to utilize going forward, but we will have more inputs and further information once we have the regulatory feedback as be explained.
Boobalan Pachaiyappan
Okay, thanks for the clarity. So, with respect to the RHB-107 Phase 2/3 study, the data readout is expected in first quarter 2022. So, can you remind us whether you expect to report any preliminary efficacy data in addition to the safety?
Dror Ben-Asher
Sure. So, the RHB-107 study is two stage study. Part A is the part that we're currently completed enrollment for and expect topline readouts in Q1. This was a 60 patients part of the study, evaluating primarily the safety aspects of the two doses that we are evaluating and that will be the main outcome.
We will get, of course, and capture also efficacy endpoints and parameters, but given the relatively small size of the cohort, we don't expect to have clear indications on efficacy, but we may follow signals that we get and certainly, select a dose for optimal productivity going forward into the part B of the study, which will be the main part with efficacy.
Boobalan Pachaiyappan
Okay, thanks for the clarity. So, yes, with respect to RHB-107, are there any benefits limitations from a safety efficacy perspective in targeting serine proteases in COVID treatment? Also, are you aware of any competitors working in this space?
Dror Ben-Asher
So, in terms of the safety aspect, RHB-107 has been studied already even prior to COVID and other indications, extensively clinically, over 200 -- 400 I think patients altogether and the safety aspects are very well-established and adequate for treating the early stage patients -- outpatients of COVID-19. In fact, RHB-107 was provided on longer term basis in other indications. So, we're not concerned about safety aspects.
In terms of the second part of the question, can you remind me what else you asked?
Boobalan Pachaiyappan
Yes, just curious whether there are any -- are you aware of any competitors working in this space?
Dror Ben-Asher
In terms of the protease inhibitors, there are competitors that are targeting protease inhibitors or other compounds in a similar class. The serine proteases that our viral targeted, like the Pfizer drug are different class and different targets.
Boobalan Pachaiyappan
All right. Thanks for taking my questions. Congrats again.
Dror Ben-Asher
Thank you.
Operator
Thank you. We will now be taking our next question that comes from the line of David Hoang from SMBC. Your line is now open, you may ask your question.
David Hoang
Hey. Thank you for taking the questions. So, I had a few here. First one, just on, I guess, the scenario expectations for your discussions with regulators regarding the opaganib post-hoc analysis, you talked about running a confirmatory trial in using FIO2 to select patients. Is that -- I guess, is that definitely occurring? Or is that subject to regulatory feedback? Or any other factors in terms of your decision to pursue another trial?
Gilead Raday
Sure. Thank you, David. Certainly, everything that we have discussed is subject to the regulatory feedback that we will receive with -- according to the timelines that we illustrated of the expected feedback, initial feedback. Certainly, for further full approval processes, it's quite clear that additional study in the target population is likely to be required. The question will be that of timing, in terms of whether it is in parallel or prior to any other potential emergency uses in parallel to the study that we may contemplate.
And of course, the use of FIO2 is a selected parameter of the target population. Again, we think that it's very feasible and makes a lot of sense. But we will get regulatory feedback in that respect also.
David Hoang
Okay, got it. Thanks for that. And then on Talicia, I just had a question maybe you can helped me understand a little bit in terms of squaring the excellent script growth you're seeing in Talicia with the revenues reported for the quarter. So, can you just give a sense of maybe what type of rebating is going on for the product? And is there -- has there been any material change into gross to net for Talicia over recent quarters?
Dror Ben-Asher
Thank you, David. It's Dror here. Specific numbers for rebaiting is not something that any company would disclose. However, we can make general comments and I'll refer this to Bob.
Bob Gilkin
Yes, thank you Dror. Appreciate that. We are well within industry standards, probably doing a little bit better than industry standards as it relates to rebate contracting with our payer customers. We are -- we take a very conservative approach to discounting, we really watch our gross to net, we've been very fortunate with a product like Talicia, where the clinical attributes of the products are really the how it fares and does much better than the clarity base therapies really provides an advantage for us and payers do see the value in the product. So, we've been very fortunate on that front. But we've been able to maintain and hold on to that rebate line.
One of the challenges that we do see is that payers continue to increase rebates and more deductibles that we're seeing across the board. So, obviously, we're trying to kind of manage that and make sure that our products are affordable for our patients. Thank you.
David Hoang
Great, really appreciate you sharing that. And then just last question on RHB-104 and Crohn's disease. I guess do you provide any more color on the maybe expected timelines for further development there and your level of confidence in being able to secure the companion diagnostic tests?
Dror Ben-Asher
Thank you, David. Its Dror. I'm glad you asked because we are as committed as ever to RHB-104 for Crohn's disease. We have been asked by investors and numerous patients on a daily basis from all over the world what is happening with this program? How can we access this product for compassionate use? Numerous questions on a daily basis.
And we do understand that this is a potential breakthrough in the treatment paradigm. And the Phase 3 results that the Guy mentioned briefly, are robust and very, very promising. We're aware of all that. But in the last three or four years, we were reluctant to move forward into a confirmatory Phase 3 study without making sure that we are right on target when it comes to the patient population.
And the right types of patient population directly related to our suggested mechanism of access is Mycobacterium avium paratuberculosis infected Crohn's patients, as opposed to all-comers. Even though we were very successful in all-comers.
And very recently, there was, for the first time a peer-reviewed publication that disclosed a very important progress in detecting MAP which we believe gives us a decent chance of running the study that we always dreamed of.
Now, to the timelines, we expect to have some kind of idea about validating the test within weeks and we are highly committed to this program. So, we intend to go to the regulators quickly with proposed design and take it from there.
I'll remind you that the Holy Grail in Crohn's treatment is mucosal healing imaging and the mucosal healing data, which is completely objective from our Phase 3 study is very, very promising. We've shown significance in mucosal healing, despite a relatively small number of patients. So, again, we are very excited about this program and we are fully committed to moving it forward as quickly as possible because the patients are waiting for it and now, it seems that at last, we have a way forward.
David Hoang
Okay, thanks for the additional color Dror really appreciate it. That's it for me.
Operator
Thank you. We will now be taking our next question that comes from the line of Bert Hazlett from BTIG. Your line is now open. you may ask your question.
Robert Hazlett
Yes, thank you. Congratulations on the progress, especially impressed with Talicia and the efforts you're making there. Do you have any anecdotal -- along those lines, do you have any anecdotal evidence or circumstances you can present with regard to field force engagement? How's the traction growing or not with regard to your sales effort? And is -- could you describe the market a little bit, is it improving the diagnosis of the condition actually improving itself? Thank you.
Dror Ben-Asher
Thank you very much, Bert. Wonderful questions. I'll refer them to Rob.
Rob Jackson
Thank you Dror. Great question. We're definitely seeing a lot of improvement in what's happening in the field. I mean our team is executing better, but we're also seeing a lot of growth week-after-week, not only in volume, but also in consistency. So, I would say the traction is definitely improving in the field for Talicia.
In terms of the diagnostic component, I think the conditions have certainly improved if you go back to the peak of COVID last year or earlier this year, a lot of prescribers were not performing breath testing, for obvious reasons, as well as endoscopic biopsies in the hospital that has changed significantly. So, the -- although COVID is still a bit of an issue for us out there, it's certainly better than it was at the beginning of the year.
Robert Hazlett
Okay, thank you for that. And then maybe you mentioned it, and maybe I missed it, my apologies. Is there any chance you could give us a breakdown of revenue may be in percentage terms of Movantik versus Talicia in the quarter? Thank you for that. And apologies if I've missed it.
Micha Ben-Chorin
Sure. Thank you, Bert, this is Micha. So, about a little over $19 million coming from Movantik and almost $2.25 million coming from Talicia.
Micha Ben-Chorin
Terrific. Looking forward to hearing of the growth of Talicia going forward. Thanks.
Operator
Thank you. We will now be taking our next question that comes from the line of Scott Henry from ROTH Capital. Your line is now open, you may ask your question.
Scott Henry
Thank you and good morning or afternoon, possibly over there. I have a couple questions on the commercial operations and I may be a little more critical, but that's only because I want to understand exactly what's going on there.
Sequentially, from 2Q to 3Q, revenues only went up about $100,000. So, I have to assume Movantik was down sequentially, is that the correct assumption? And is that seasonal or how should we be thinking about that?
Dror Ben-Asher
Thank you. Its Dror here. No, it's not related at all. Doctor referrals and scripts are very different things sometimes.
Scott Henry
Okay. But Dror as you can see revenue is going down--
Micha Ben-Chorin
But I can add there Scott that both revenues from Movantik and Talicia went up and we took a negative impact from Aemcolo. So, both Talicia and Movantik are up.
Scott Henry
Can you give me any idea of how large the negative impact on Aemcolo was?
Micha Ben-Chorin
It's not very big. It's towards the neighborhood of $100,000.
Scott Henry
Okay. And with regards to Aemcolo, what are your thoughts there? Is it burning a lot of cash marketing the product, it means there's virtually no revenues coming from it, but I don't know -- which is understandable given COVID, but what -- is it taking a lot of resources is the question and how long can you keep doing that?
Dror Ben-Asher
Thank you Thank you, Scott about. I'll let Rob answer. Obviously, before I turn to Rob, the pandemic has had a very negative impact on travel to high risk territories. Therefore, what we have said in the beginning right before the pandemic with Aemcolo, which was very nice trend has come to a halt -- complete halt. I'll let Rob explain what we are doing right now in terms of our own investment, we're big believers in the product as the pandemic gradually hopefully eases. Rob?
Rob Jackson
Thank you, Dror. To answer the question relative to Movantik and Talicia, Aemcolo is taking very few resources right now. It's typically in a second or third position detail when the opportunity arises. So, I would not be concerned looking at this from the outside that we're overweighting our effort or our spend on Aemcolo relative to what we're able to deliver right now during the pandemic.
Scott Henry
Okay, I guess Rob and this is a question for you, because I know you sound very enthusiastic about the direction of the commercial division. But when I look at it, I mean, yes, the loss went way down in Q3 from Q2. But that's largely because it went way up from Q1 to Q2. So, I mean, if I compare Q3 to Q1, the story isn't as attractive.
So, my question is, when are we going to see an inflection point and really start to get that loss in a declining mode versus up one quarter, down one quarter? When can we see a sustainable improvement? Thank you.
Dror Ben-Asher
Rob, would you like to take this?
Rob Jackson
Sure. Certainly, in terms of Talicia, we are seeing a sustainable improvement. If you look at the slide in our deck for Talicia, we break out the prescription volume by month, you will see that there has been a sustainable improvement since the end of second quarter.
We have put more focus on Talicia second half of the year and we're definitely seeing an uptake and I know, based on what I'm seeing already, I'm very confident we're going to have a strong fourth quarter as well. So, we're heading in the right direction. And if you take that and combine that with the Medi-Cal win we have, it's going to kick into effect in January of next year.
I think between the sustained performance we're seeing in our core business plus what we'll get for Medicaid plus potentially some spillover there on the commercial side, I expect we'll be able to continue that trend right through 2022 and continue to accelerate.
Scott Henry
Okay. Just looking forward to seeing that commercial breakeven. And when I speak of the trends, obviously, I see the Talicia scripts every week, they look great, but just want to see that loss start to decline, because it is still a significant number. But shifting gears, I did want to ask the gross margin in the quarter looked pretty good. How should we think about that going forward?
Micha Ben-Chorin
So, you're right that we have a substantial increase this quarter and this is compared to previous two quarters in which we had the smaller margin mainly due to the shorter exploration of Talicia which comprise the part of the of the inventory and the channel.
And now after we got the FDA extension of the expiration from two years to three years, this is -- allows us to much better flexibility in the operations and also contribute to the increase margin. So, we will see an increase of margin going forward is compared with Q1 that you mentioned for example.
Scott Henry
So, I guess, what I'm saying is do you think Q3 gross margin, can you maintain that level going forward from Q3 number?
Micha Ben-Chorin
Q4 may be a little lower than Q3, but above Q1 and Q2 gross margins.
Scott Henry
Okay, that's helpful. Thank you. And then your final question -- I think it'll be the final. On opaganib, if you do have to do a confirmatory trial, how long do you think that would take from start to finish?
Gilead Raday
Thanks Scott. Gilead here. We think the last study that enrolled 450 -- over 450 patients actually was completed in a year -- close to a year. We think that given the positive data from the study targeted to the right population of the moderately severe hospitalized patients, we can probably do better than that. And given resources and potential support from external sources also, these public platforms or other sources, we could go even broader in terms of the number of sites and get the study done in under a year. So, that would be our target.
Scott Henry
Okay, great. Thank you for that color. And thank you for taking the questions.
Dror Ben-Asher
Thank you.
Operator
Thank you. So, no further question came through. Sir, please continue.
Dror Ben-Asher
Thank you, Brian. Thank you all for joining the call. Please feel free to reach out to us if you have any additional questions. Keep safe and have a pleasant day.
Operator
Thank you. That does conclude the conference for today. Thank you all for participating. You may all disconnect.
RedHill Biopharma Ltd. 2021 Q3 - Results - Earnings Call Presentation
Nov. 30, 2021 11:38 AM ETRedHill Biopharma Ltd. (RDHL), REDIF
The following slide deck was published by RedHill Biopharma Ltd. in conjunction with their 2021 Q3 earnings call.
https://seekingalpha.com/article/4472541-redhill-biopharma-ltd-2021-q3-results-earnings-call-presentation?utm_campaign=RTA+Articles&utm_medium=email&utm_source=seeking_alpha&utm_term=RTA+Article+Smart
RedHill Biopharma Reports Operational Highlights and Third Quarter 2021 Financial Results
https://finance.yahoo.com/news/redhill-biopharma-reports-operational-highlights-120000667.html
RedHill Accelerates its Two Advanced COVID-19 Pill Clinical Programs in Light of their Potential Against Omicron
Acting independently of spike protein mutation, opaganib and RHB-107's unique host-targeted mechanisms of action hold potential versus Omicron and other variants
-- Phase 2/3 study sub-population analysis demonstrated a 62% reduction in mortality in moderately severe hospitalized patients; Data packages submitted in the U.S., EU (EMA has provided expedited evaluation process timelines), UK and other territories, ahead of regulatory advice
-- Top-line data from Part A of the COVID-19 Phase 2/3 study of RHB-107 (upamostat) in non-hospitalized symptomatic COVID-19 patients in the U.S. and South Africa expected in Q1/2022
-- Second consecutive quarter of record net revenues with $21.6 million for Q3/2021 and an increase in gross margin and steep reduction in operating and net loss; Cash balance[1] of $51.5 million as of September 30, 2021
-- Strategic investment in RedHill by South Korea's Kukbo Co. of up to $10 million as well as a $15.5 million underwritten public offering in November
-- Another record quarter for Talicia® revenues, with new prescription volume up 15%, reflecting 117% growth vs. Q3/2020; Movantik® continues to rise with an increase in quarterly new prescriptions of 1.1%
-- Continued prescription volume growth seen into the fourth quarter to date for both Talicia and Movantik, with coverage increase on both commercial and government formularies
-- Management to host webcast today, at 8:30 a.m. EST
TEL AVIV, Israel and RALEIGH, N.C., Nov. 30, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its financial results and operational highlights for the third quarter ended September 30, 2021.
Dror Ben-Asher, RedHill's Chief Executive Officer, said: "Our U.S. commercial business continues to drive growth, delivering a second consecutive quarterly net revenue record of $21.6 million despite the continuously challenging pandemic environment. Talicia generated another record quarter with 15% growth in new prescriptions, while Movantik continues to perform adding a 1.1% increase to new prescriptions. Both products are also continuing to make strides in gaining both commercial and government formulary coverage. In addition, gross margin increased from 51% in the second quarter to 57% in the third quarter. The Company has successfully attracted a strategic investment from South Korea's Kukbo and continues to demonstrate responsible financial discipline across the entire business as we strive to achieve our long-term growth aims."
Mr. Ben-Asher added: "Given the recent emergence of the heavily mutated Omicron variant as well as likely emergence of other variants over time, the importance of drug candidates that act independently of the viral spike protein is growing. This makes both opaganib and RHB-107's host-targeted mechanism of action, and expected maintenance of effect against new variants, increasingly more relevant in the battle against COVID-19. This quarter saw significant focus on our opaganib Phase 2/3 COVID-19 study. The initial top-line results demanded further investigation and our rigorous post-hoc analysis provided much greater clarity into the potential of novel, orally-administered opaganib in the underserved hospitalized moderately severe patient group. This is a group of patients for which no novel therapeutic pill has shown a benefit until opaganib, which demonstrated a 62% reduction in mortality, improved return to room air and earlier hospital discharge for opaganib-treated patients. The results of this analysis, in a group of more than half the total study population, were consistent with what we had seen in our Phase 2 study and compassionate use experience. Despite being a post-hoc analysis, the consistency across multiple endpoints and territories provides us with a high degree of confidence in the results showing opaganib's effect in this patient population. This analysis also shed light on key issues of the COVID-19 disease severity classification, suggesting that FiO2 might be an improved method for classifying disease severity and predictor of treatment outcome. We have now provided regulators in various countries with all the necessary data to facilitate discussions on the next steps and we continue to provide the data to regulators in additional countries."
"In parallel, we continue to progress our Phase 2/3 study in the U.S. and South Africa with our other novel, once-daily, oral COVID-19 antiviral drug candidate, RHB-107, which has now completed enrollment for Part A of the study, with top-line results expected in the first quarter of 2022. Our Phase 3 study of RHB-204 in pulmonary nontuberculous mycobacteria (NTM) disease continues to enroll patients in the U.S. and progress with Phase 3-stage RHB-104 for Crohn's disease is expected to speed up thanks to recent, much-awaited, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) detection research[2]."
"With a steep reduction in quarterly operating and net loss and continued commercial business growth, leading to a potential commercial operational breakeven before the end of the year, coupled with advanced, exciting and timely R&D pipeline progress, I believe RedHill is well positioned for short, medium and long-term success."
Financial highlights for the quarter ended September 30, 2021[3]
Net Revenues were $21.6 million for the third quarter of 2021, as compared with $21.5 million for the second quarter of 2021. The increase is attributable to an increase in sales of Talicia and Movantik, partially offset by an increase in gross-to-net deductions, mainly commercial rebates and Medicare discounts.
Gross Profit was $12.4 million for the third quarter of 2021, compared to $10.9 million for the second quarter of 2021 - an increase of 14%. Gross margin increased from 51% in the second quarter of 2021 to 57% in the third quarter of 2021. The increase in gross profit was mainly attributable to a reversal of inventory write-off recognized in the third quarter of 2021 following the FDA approval of an extension to Talicia stock expiration date.
Research and Development Expenses were $5.8 million for the third quarter of 2021, a decrease of $4.5 million, a 44% reduction compared to the second quarter of 2021, mainly attributable to the completion of our global COVID-19 Phase 2/3 study with opaganib.
Selling, Marketing and General and Administrative Expenses were $24 million for the third quarter of 2021, a decrease of $1.5 million compared to the second quarter of 2021. The decrease was mainly attributable to expenses related to share-based compensation in the previous quarter.
Operating Loss and Net Loss were $17.4 million and $21.4 million, respectively, for the third quarter of 2021 compared to $24.9 million and $29.1 million, respectively, in the second quarter of 2021. The decrease was mainly attributable to the Talicia inventory expiration date extension, completion of our opaganib Phase 2/3 COVID-19 study and a decrease in expenses related to share-based compensation, as detailed above.
Net Cash Used in Operating Activities was $19 million for the third quarter of 2021, similar to the second quarter of 2021.
Net Cash Used in Financing Activities was $1 million for the third quarter of 2021, comprised primarily of payables with respect to the Movantik acquisition, partially offset by proceeds from utilization of ATM and from exercise of options.
Cash Balance1 as of September 30, 2021, was $51.5 million.
Additional Financial Highlights
In November 2021, the Company announced that it had entered into a strategic agreement with Kukbo Co. Ltd., a South Korean corporation, for the sale of RedHill's American Depositary Shares (ADSs) in a private placement of up to $10 million, of which the first tranche of $5 million has been paid. As part of the agreement, the Company granted Kukbo a six month right of first offer for a license with respect to one or more of opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories.
In addition, this month, the Company completed an underwritten public offering of approximately 4.7 million ADSs for gross proceeds of approximately $15.5 million, led by Cantor Fitzgerald.
Commercial Highlights
Movantik® (naloxegol)[4]
The Company's focus on driving Movantik performance and strengthening of market share continues unabated, resulting in another quarter of new prescription growth, increasing by 1.1% compared to the previous quarter.
The Company has achieved significant market access successes with U.S. major payors, continuing to increase the levels of payor coverage.
In July, one of America's largest payors, serving many Blue Cross and Blue Shield Plans and more than 30 million members, had added Movantik as a preferred brand with no restrictions to its Commercial NetResults "A" series formularies and as a preferred brand on its other commercial formularies starting July 1, 2021. In April, Movantik was also included on the Part D formulary of another major payor with no restrictions. Almost 9 out of 10 U.S. commercial lives are now covered, and we continue to work toward additional formulary coverage for the remaining patients.
In September 2021 RedHill Biopharma Inc., AstraZeneca AB, AstraZeneca Pharmaceuticals LP and Nektar Therapeutics entered into a settlement and license agreement with Aurobindo Pharma USA, Inc. resolving their patent litigation in the U.S. in response to Aurobindo's Abbreviated New Drug Application (ANDA) seeking approval by the FDA to market a generic version of Movantik. This follows the previously announced resolution of the Apotex litigation and brings to a close all presently pending Movantik patent litigation brought pursuant to The Drug Price Competition and Patent Term Restoration Act (the Hatch-Waxman Act). The earliest licensed entry date of any generic naloxegol in the U.S. is October 1, 2030.
Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[5]
Talicia achieved another record quarter, delivering a 15% increase in new prescriptions, compared to the previous quarter, reflecting 117% growth of Talicia as compared to Q3/2020.
In October, Medi-Cal - California's Medicaid Health Care program covering two million beneficiaries - had added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required. This coverage is expected to expand to 14 million beneficiaries on January 1, 2022. During the same month, a new U.S. Patent covering Talicia was granted. This patent reinforces the protection for Talicia through 2034, and the Company has listed this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
In July, the Company significantly expanded commercial coverage for Talicia, announcing that OptumRx, part of the UnitedHealth Group, a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals and 6,500 hospitals, had added Talicia to its Commercial Formulary as an unrestricted brand for H. pylori treatment, effective July 1, 2021. This agreement expanded access to Talicia to 26 million additional Americans and increased overall patient access to Talicia to greater than 8 out of 10 covered U.S. Commercial lives.
Aemcolo® (rifamycin)[6]
The Company has maintained promotion of Aemcolo in the third quarter of 2021 supporting the initial momentum that Aemcolo was generating pre-COVID-19 travel restrictions. RedHill and Cosmo Pharmaceuticals N.V are currently in discussions with respect to the amendment of the Aemcolo License Agreement.
R&D Highlights
COVID-19 Program: Opaganib (ABC294640)[7]
In September 2021, the Company announced top-line results from the global 475-patient Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia (NCT04467840). Whilst results showed consistent trends in favor of the opaganib arm, the study endpoints did not achieve statistical significance.
A post-hoc analysis of data from 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (54% of the study participants), was subsequently reported in October 2021, demonstrating that treatment with oral opaganib resulted in a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge, in this large group of hospitalized, moderately severe COVID-19 patients.
The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher.
Additional new preclinical results demonstrating opaganib's efficacy in significantly decreasing renal fibrosis in a unilateral ureteral obstruction-induced renal interstitial fibrosis mode were also reported by the Company in September 2021.
The Company has submitted data packages for opaganib to the regulatory agencies in the U.S., EU, UK and other territories, ahead of planned regulatory advice, with the European Medicines Agency (EMA) having provided expedited evaluation process timelines. As previously stated, additional studies to support the potential of such applications and the use or marketing of opaganib are likely to be required. For example, the FDA has previously indicated that we will need to complete additional studies to support applications in the U.S. The strength of the safety and efficacy data generated from the opaganib studies will be key to regulatory applications.
The Company also continues its discussions with U.S. and other government agencies and non-governmental organizations around potential funding to support the ongoing development of opaganib. Discussions are also ongoing with potential partners who are interested in the rights to opaganib in various territories.
COVID-19 Program: RHB-107 (upamostat)[8]
RedHill continues to advance the Phase 2/3 study of novel, once-daily, orally-administered, antiviral drug candidate, RHB-107, in the treatment of non-hospitalized patients with symptomatic COVID-19 in the early course of the disease who do not require supplemental oxygen - the vast majority of COVID-19 patients. The study plans to test for the Omicron variant.
Further to announcing in September 2021 that South Africa had joined the U.S. in approving the Phase 2/3 study, along with the expansion to additional U.S. sites, the Company announced this month that the last patient had been enrolled in Part A of the Phase 2/3 study. The study is a 2-part trial designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and based on safety and tolerability results of part A, a dose for part B will be selected. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.
RHB-204 - Pulmonary Nontuberculous Mycobacteria (NTM) Disease
A U.S. Phase 3 study is ongoing to evaluate the efficacy and safety of RHB-204 in adults with pulmonary NTM disease caused by Mycobacterium avium Complex (MAC) infection. The Company is also assessing potential expansion of the RHB-204 Phase 3 study to additional territories.
The Company previously announced that the FDA granted Fast Track designation for RHB-204, providing early and frequent communications and a rolling review of any New Drug Application (NDA). RHB-204 is also eligible for NDA Priority Review and Accelerated Approval.
RHB-204 was granted FDA Orphan Drug designation and Qualified Infectious Disease Product designation, extending its U.S. market exclusivity to a potential total of 12 years upon potential FDA approval.
RHB-104 - Crohn's Disease
Based on recent published research, potential progress in Mycobacterium avium subspecies paratuberculosis (MAP) diagnostic technology may enable us to advance the program towards a confirmatory study in approximately 150 MAP positive moderate-severe Crohn's patients, subject to required regulatory input.
Opaganib - Prostate Cancer and Cholangiocarcinoma
In August 2021, we announced that, based on a preliminary review of partial and unaudited data, the ongoing Phase 2 study for prostate cancer had met its primary endpoint of at least six subjects demonstrating disease control (defined as stable disease or better after 16 weeks on treatment) among at least 27 evaluable subjects. Upon further review and analysis of the unaudited data, the Company reported that the study did not meet its primary endpoint in the study arm evaluating opaganib in combination with enzalutamide. Patient enrolment continues for the study's other arm, evaluating a combination of opaganib and abiraterone. Accrual and data entry are ongoing and results for the study remain subject to further review and analysis.
The Phase 2a study evaluating the activity of opaganib in advanced cholangiocarcinoma (bile duct cancer) is ongoing at Mayo Clinics in Arizona and Minnesota, Emory University and the Huntsman Cancer Institute at the University of Utah. Enrollment has been completed for the first cohort of 39 patients, evaluating the activity of orally-administered opaganib as a stand-alone treatment. Preliminary data from this cohort indicated a signal of activity in a number of subjects with advanced cholangiocarcinoma. Enrollment is ongoing for a second cohort, evaluating opaganib in combination with hydroxychloroquine, an anti-autophagy agent.
Conference Call and Webcast Information:
The Company will host a webcast today, Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.
The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:
+972-3-530-8845; the access code for the call is: 9753927.
RedHill Biopharma to Host Third Quarter 2021 Financial Results and Operational Highlights Webcast on November 30, 2021
https://finance.yahoo.com/news/redhill-biopharma-host-third-quarter-120000923.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 24, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it will report its third quarter 2021 financial results and operational highlights on Tuesday, November 30, 2021.
The Company will host a webcast on Tuesday, November 30, 2021, at 8:30 a.m. EST, during which it will present key highlights for the third quarter of 2021.
The webcast including slides will be broadcast live on the Company's website, https://ir.redhillbio.com/events, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1-646-741-3167 and Israel:
+972-3-530-8845; the access code for the call is: 9753927 .
RedHill Biopharma Announces Closing of $15.5 Million Public Offering of American Depositary Shares
https://finance.yahoo.com/news/redhill-biopharma-announces-closing-15-161000809.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 23, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the closing of the previously announced underwritten public offering of approximately 4.7 million American Depositary Shares ("ADSs") for gross proceeds of approximately $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs were offered by RedHill. In addition, RedHill has granted the underwriter a 30-day option to purchase up to approximately an additional 0.7 million ADSs.
Well - they have done the ‘F them’ to us.
My 2nd worst investment by far - lesson for me is - how not to believe management, be always skeptical and book losses and run away.
Bad management never improves and expecting as such is a miracle.
HOW MANY TIMES ARE THESE SCUMBAGS GOING TO DILUTE
"S.O.B.!" Did you see today's price? Pretty soon we will be able to get RDHL for a dollar a share! I hope my other stocks do well, so I can use RDHL as a tax write-off! Damn it!!!
RedHill Biopharma Announces Pricing of $15.5 Million Public Offering of American Depositary Shares
https://finance.yahoo.com/news/redhill-biopharma-announces-pricing-15-140000358.html
TEL AVIV, Israel and RALEIGH, N.C., Nov. 19, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the pricing of an underwritten public offering of 4.7 million American Depositary Shares ("ADSs") for gross proceeds of $15.5 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by RedHill. Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. All of the ADSs are being offered by RedHill. The closing of the offering is expected to occur on or about November 23, 2021, subject to the satisfaction of customary closing conditions. In addition, RedHill has granted the underwriter a 30-day option to purchase up to an additional 0.7 million ADSs.
Cantor Fitzgerald & Co. is acting as sole bookrunner for the offering.
The underwriter may offer the ADSs from time to time for sale in one or more transactions on the Nasdaq Global Market, in the over-the-counter market, through negotiated transactions or otherwise at market prices prevailing at the time of sale, at prices related to prevailing market prices or at negotiated prices. On November 18, 2021, the last sale price of the ADSs as reported on the Nasdaq Global Market was $3.88 per ADS.
RedHill intends to use the net proceeds of the offering to fund its commercialization activities, clinical development programs and for acquisitions and general corporate purposes.
Pfizer moves to allow cheaper COVID-19 pills sending shares of rivals lower
Nov. 16, 2021 9:04 AM ETModerna, Inc. (MRNA), AZN,BNTX,RHHBYPFE, JNJ, MRK,AVIR,RDHL,ADGI,VIR,REGN,LLY,GILD
By: Dulan Lokuwithana, SA News Editor
Established COVID-19 vaccine makers have come under pressure after Pfizer (NYSE:PFE) and a United Nations-backed public health organization announced a licensing pact to allow generic-drugmakers to produce cheaper versions of the company’s experimental COVID-19 pill.
Moderna (NASDAQ:MRNA), AstraZeneca (NASDAQ:AZN), and Pfizer’s (PFE) partner in COVID-19 vaccine development BioNTech (NASDAQ:BNTX) have lost ~1.4%, ~3.1%, and ~1.0% in the pre-market, respectively. Johnson & Johnson (NYSE:JNJ) and is trading flat.
The licensing deal by Pfizer (PFE) to enable wider access to its COVID-19 therapeutic follows a similar deal from the rival drugmaker Merck (NYSE:MRK) for its investigational pill, molnupiravir. Merck (MRK) has shed ~1.0% in early trading.
The shares of early-stage developers of oral COVID-19 therapies such as Atea Pharmaceuticals (NASDAQ:AVIR)/ Roche (OTCQX:RHHBY), RedHill Biopharma (NASDAQ:RDHL), and Adagio Therapeutics (NASDAQ:ADGI) are also expected to open lower.
Stocks to watch: Established manufacturers of COVID-19 antibody treatments such as Vir Biotechnology (NASDAQ:VIR), Regeneron (NASDAQ:REGN), Eli Lilly (NYSE:LLY) as well as Gilead (NASDAQ:GILD), which produces the intravenously administered COVID-19 therapy Remdesivir.
In terms of effectiveness, Pfizer (PFE)) and its rival Merck (MRK) have demonstrated about 89% and ~50% effectiveness for their oral COVID-19 drugs, PAXLOVID, and molnupiravir in late-stage trials, respectively.
RedHill Biopharma Ltd Announces RedHill: LPI in Part A of RHB-107 P2/3 COVID Study
https://finance.yahoo.com/news/redhill-biopharma-ltd-announces-redhill-120200532.html
RedHill Biopharma Announces Last Patient Randomized in Part A of Ongoing Phase 2/3 COVID-19 Study of Once-Daily Oral RHB-107 in Non-Hospitalized Patients
Recruitment completed for Part A of the Phase 2/3 study of once-daily orally-administered RHB-107 (upamostat) for patients with symptomatic COVID-19 who do not require hospital care
Top-line results for Part A of the study, designed to evaluate safety and tolerability of RHB-107 and dose selection, expected in Q1/ 22
RHB-107 is a novel, investigational antiviral serine protease inhibitor targeting human cell factors and is expected to be effective against emerging viral variants
In parallel, data packages for opaganib, RedHill's other advanced novel oral COVID-19 drug candidate, have been submitted in the U.S., EU, UK and other territories, ahead of planned regulatory advice
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 15, 2021 / RedHill Biopharma Ltd. (Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that the last patient has been enrolled in Part A of the Phase 2/3 study with novel, once-daily, orally-administered pill RHB-107 (upamostat)[1] for non-hospitalized patients with symptomatic COVID-19. The study is being conducted in the U.S. and South Africa.
The Phase 2/3 study (NCT04723527) with RHB-107 is aimed at evaluating treatment in patients with symptomatic COVID-19 early in the course of the disease, with a once-daily oral treatment that can be prescribed and used in the non-hospitalized patient population. The study is a 2-part, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of RHB-107. The study is designed to evaluate time to sustained recovery from illness as the primary endpoint and for dose selection. A total of 61 patients have been enrolled in Part A and randomized on a 1:1:1 basis to receive one of two doses of upamostat or placebo. Based on safety and tolerability results of part A, a dose for part B will be selected, and patients will be randomized 3:2 to active vs. placebo. Patients are also tested for specific viral strain. Top-line results from Part A of the study are expected in the first quarter of 2022, with Part B of the study expected to follow subsequent to discussions with regulators.
"Once again, we see a rise in COVID-19 infections in many countries across the world - and the need for effective, simple and safe oral therapies that can be used outside the hospital setting, and that can work across COVID-19 variants, is significant," said Terry F. Plasse MD, Medical Director at RedHill. "Completing randomization for Part A of the RHB-107 Phase 2/3 study is an important step forward for this elegant, once-daily novel oral pill as a potential treatment of COVID-19 in the community."
RHB-107 is a novel antiviral drug candidate that targets human serine proteases involved in preparing the spike protein for viral entry into target cells. Because it is host-cell targeted, RHB-107 is expected to also be effective against emerging viral variants with mutations in the spike protein. RHB-107 has demonstrated strong inhibition of SARS-CoV-2 viral replication in an in vitro human bronchial epithelial cell model. RHB-107 has a strong clinical safety and biodistribution profile, demonstrated in previous clinical studies, including several Phase 1 and Phase 2 studies in different indications, in approximately 200 patients.
In parallel, data packages for opaganib[2], RedHill's other advanced novel oral COVID-19 drug candidate - have been submitted to regulators in various territories including the U.S., EU, UK and others, ahead of planned regulatory advice. Opaganib's global Phase 2/3 study in patients hospitalized with severe COVID-19 demonstrated a 62% reduction in mortality as well as improved outcomes in time to room air and median time to hospital discharge in a sub-group of 251 moderately severe patients, comprising 54% of the study participants.
RedHill Biopharma to Present at H.C. Wainwright 7th Annual Israel Conference and German Equity Forum (EKF) 2021
https://finance.yahoo.com/news/redhill-biopharma-present-h-c-120000312.html
TEL-AVIV, Israel and RALEIGH, N.C., Nov. 9, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Guy Goldberg, RedHill's Chief Business Officer, will present an overview of the Company and host 1-on-1 investor meetings at the following virtual conferences in November:
H.C. Wainwright 7th Annual Israel Conference - November 15, 2021
Presentation: Monday, November 15, 2021, at 8:00 a.m. EST
Webcast: Live and on-demand for 30 days: https://www.redhillbio.com/investors
German Equity Forum (Deutsches Eigenkapital Forum, EKF) - November 22-24, 2021
Presentation: Tuesday, November 23, 2021, at 14:30 CET / 8:30 a.m. EST
Webcast: On-demand after the conference for 30 days: https://www.redhillbio.com/investors
RedHill Biopharma and South Korea's Kukbo Co. Announce a Strategic Investment of Up To $10 Million in RedHill
https://finance.yahoo.com/news/redhill-biopharma-south-koreas-kukbo-121500390.html
RedHill received the first tranche of $5 million in a private placement of restricted stock priced at $6.04 per ADS, representing a 20% premium based on the 30 trading days' volume weighted average price (VWAP) ending on the effective date
RedHill granted Kukbo a right of first offer for opaganib, RHB-107 (upamostat) and Talicia® for South Korea and other Asian territories
Opaganib's COVID-19 data packages submission process is advancing in various territories including the U.S., EU, Latin America and others, ahead of planned regulatory advice
TEL AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / November 8, 2021 /RedHill Biopharma Ltd.(Nasdaq:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it has entered into a strategic agreement with Kukbo Co. Ltd. (Kospi: 001140) ("Kukbo"), a South Korean corporation, for the sale of RedHill's American Depositary Shares ("ADSs") in a private placement of up to $10 million at a 20% premium to the prior 30 trading days' volume weighted average price ("VWAP").
Kukbo's strategic investment in RedHill is to be made in two tranches, with the first tranche of $5 million already paid and the second tranche of $5 million to follow within six months, subject to satisfaction of certain conditions. As part of the first tranche, RedHill is to issue 827,586 ADSs at a purchase price of $6.04, representing a 20% premium based on the VWAP of RedHill's ADS on NASDAQ over the 30 trading days ending on the effective date. All ADSs are to be issued with a 180-day transfer restriction.
In addition, under the terms of the agreement, RedHill has agreed to grant Kukbo a right of first offer, for a period of six months, for a license with respect to one or more of RedHill's late-stage clinical assets, opaganib, RHB-107 (upamostat)[1] and Talicia®, for one or more of the territories of South Korea, Japan, Indonesia, Vietnam, Thailand and Malaysia. Kukbo has the right to elect not to purchase the ADSs in the second tranche if no such license agreement is executed within six months of the closing of the first tranche.
Dror Ben-Asher, RedHill's CEOsaid: "We are rapidly advancing with opaganib's COVID-19 data package submissions to regulators in several territories including the U.S., EU and others, ahead of planned regulatory advice. We are pleased with the addition of Kukbo as a committed strategic investor and look forward to evaluating opportunities for opaganib, RHB-107 and Talicia in South Korea and other territories in Asia where large unmet medical needs exist."
"As Kukbo proceeds in its planned strategic expansion into healthcare, we believe that RedHill's opaganib, RHB-107 and Talicia, if approved, hold substantial promise in South Korea and other Asian countries and are eager to leverage our local expertise and network in those territories," said Hyun Ha, Kukbo's CEO.
Nexpedia Holdings Co., Ltd. and Network 1 Financial Securities, Inc. facilitated the introduction between the parties.
The securities to be sold in the private placement have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), or any state or other applicable jurisdiction's securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state or other jurisdictions' securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.
This will kill any hope for RDHL pill
Pfe ceo talked about capacity to mfr 500 million pills in 2022 - all others will need to get help to mfr - so they have clear advantage
Pfizer says antiviral pill cuts risk of severe COVID-19 by 89%
Nov 5 (Reuters) - A trial of Pfizer Inc's experimental antiviral pill for COVID-19 was stopped early after the drug was shown to cut by 89% the chances of hospitalization or death for adults at risk of developing severe disease, the company said on Friday.
The results appear to surpass those seen with Merck & Co Inc's pill molnupiravir, which was shown last month to halve the likelihood of dying or being hospitalized for COVID-19 patients also at high risk of serious illness.
Full trial data is not yet available from either company
-------------------------------------------------------------
Good news for mankind, bad news for RDHL
Great article - why are we stuck in low 5’s?
Price target of 22. When?
We ran over 10 several times - over 11 on 2/22/21
I’m looking for 22 on 2/22/22
Deuces Wild!!
Best Covid Vaccine and Pill Stocks To Invest In
https://finance.yahoo.com/news/11-best-covid-vaccine-pill-192121981.html
RedHill Biopharma Ltd. (NASDAQ:RDHL)
Number of Hedge Fund Holders: 4
In early October, RedHill Biopharma Ltd. (NASDAQ:RDHL) presented the results of a study into a new experimental drug, administered orally, for COVID-19 patients. The company, which operates from Israel, revealed that the drug reduced the risk of mortality in COVID-19 patients by up to 62% compared to a placebo. The share price of the firm jumped more than 6% after the results were announced.
In August, Cantor Fitzgerald analyst Brandon Folkes had initiated coverage of RedHill Biopharma Ltd. (NASDAQ:RDHL) stock with an Overweight rating and a price target of $22, noting that the firm was working on several interesting drugs, including two COVID-19 ones.
Among the hedge funds being tracked by Insider Monkey, New York-based investment firm ARK Investment Management is a leading shareholder in RedHill Biopharma Ltd. (NASDAQ:RDHL) with 787,469 shares worth more than $5.4 million.
RedHill Biopharma Presents New Talicia(R) and Movantik(R) Data Analyses at ACG 2021
https://finance.yahoo.com/news/redhill-biopharma-presents-talicia-r-110200370.html
Two new analyses evaluate pharmacological and clinical advantages of Talicia® as first-line
H. pylori therapy over clarithromycin-based regimens
-
Two new analyses of Movantik® data evaluate efficacy in treating extreme opioid-induced constipation with severe symptoms
-
Talicia®, an FDA approved therapy, is designed to replace clarithromycin-based regimens as first-line H. pylori eradication therapy; ACG Guideline recommends avoiding treatment with clarithromycin to eradicate H. pylori due to growing bacterial resistance
-
Movantik is the U.S. market-leading oral peripherally acting mu-opioid receptor antagonist (PAMORA), approved to treat opioid-induced constipation in adults with chronic non-cancer pain
TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 25, 2021 / RedHill Biopharma Ltd.(NASDAQ:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the presentation of four new analyses of Phase 3 Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] and Movantik® (naloxegol)[2] data at the ACG 2021 Annual Scientific Meeting, taking place October 22-27, 2021.
The first Talicia analysis evaluated physician-directed therapy data, confirming high utilization of clarithromycin and low rates of H. pylori eradication. Inappropriate use of clarithromycin persists despite American College of Gastroenterology (ACG) recommendations to avoid clarithromycin when treating H. pylori patients who have a history of macrolide exposure, where local resistance rates are ≥ 15% or unknown, and/or when the patient has been previously treated with a clarithromycin-containing regimen. Utilization data based on U.S. prescriptions confirmed that clarithromycin-based regimens remain predominant, even though the majority of Americans have previously been prescribed a macrolide antibiotic[3]. The authors conclude that since Talicia does not contain clarithromycin, and resistance to amoxicillin and rifabutin is very rare, Talicia can be used first-line with minimal concern for antibiotic resistance or CYP2C19 metabolism.
The second Talicia analysis assessed gastric luminal rifabutin concentrations of three times a day rifabutin 50 mg (the dose of rifabutin within Talicia®) vs. once-daily administration of rifabutin 150 mg, and the potential impact on H. pylori eradication. The data suggest that there may be a link between sustained gastric rifabutin exposure achieved with Talicia's unique dosing and formulation and the 90% eradication rates seen in clinical studies. The findings demonstrate that rifabutin dosed once-daily as 150 mg cannot replicate both the pharmacokinetic profile and therapeutic effects of rifabutin 50 mg three-times daily (as dosed in Talicia®).
"Sustained high intragastric rifabutin concentrations explain the high clinical trial eradication rates seen with Talicia and suggest that three-times daily Talicia should be considered a first-line therapy for patients with H. pylori infection." said Dr. Colin W. Howden, MD, AGAF, FACG, Professor Emeritus, University of Tennessee Health Science Center. "Contrary to ACG guideline recommendations, many physicians continue to prescribe clarithromycin-based therapies to patients, resulting in low rates of eradication because of high rates of clarithromycin resistance."
The two Movantik posters analyzed data from patients experiencing extreme opioid-induced constipation (OIC) with severe symptoms. Both Movantik 12.5 mg and 25 mg provided rapid onset with early symptom relief and consistent, predictable and sustained efficacy in improving multiple symptoms despite high baseline symptom burden. Movantik also demonstrated a favorable safety-profile and tolerability.
The two analyses included pooled data from two large, pivotal Phase 3 studies of Movantik (Kodiak 4 and Kodiak 5; NCT01309841/NCT01323790), involving 891 treated patients across two doses (12.5 mg and 25 mg), compared to a total of 446 patients in the placebo arms.
"Chronic pain patients are already subject to considerable suffering. For up to 80% of them, this is compounded by opioid-induced constipation - with a significant number suffering from extreme OIC with severe and debilitating symptoms. Movantik demonstrated both rapid and durable symptom improvement which are highly important clinical considerations in patients with OIC" said Dr. Darren M. Brenner, MD, AGAF, Associate Professor of Medicine and Surgery at Northwestern University Feinberg School of Medicine and Director of the Gastrointestinal Physiology Laboratory and Functional Bowel Programs.
Posters Presented at ACG 2021 Annual Scientific Meeting:
Talicia:
Poster number 2029
RHB-105 Q8H Rifabutin Dosing Provides Favorable Exposure for Helicobacter pylori Eradication
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Salil N. Pendse, Mark A. Bush, June S. Almenoff, Kely L. Sheldon
Poster number 3083
Pitfalls of Physician-Directed Treatment of Helicobacter pylori Infection: Results from Two Phase 3 Clinical Trials and Real-World Prescribing Data
Presenter: Dr. Colin W. Howden
Authors: Colin W. Howden, Kely L. Sheldon, June S. Almenoff, William D. Chey
Movantik:
Poster number 0386
Naloxegol Accelerates Time to First Spontaneous Bowel Movement (SBM) and Complete SBM (CSBM) with Predictable Efficacy in Patients with Extreme Opioid-Induced Constipation (OIC): A Pooled Analysis of Two Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: William Chey, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, Darren M. Brenner
Poster number 0397
Naloxegol Achieved Rapid and Sustained Improvement of Opioid-Induced Constipation (OIC) Symptoms in Patients with Extreme OIC: A Pooled Analysis of Two Pivotal Phase 3 Trials
Presenter: Dr. Darren M. Brenner
Authors: Darren M. Brenner, Carol B. Rockett, Jeremy Adler, Theresa Mallick-Searle, Enoch Bortey, William Chey
About Talicia®
Talicia® is the only rifabutin-based therapy approved for the treatment of H. pylori infection and is designed to address the high resistance of H. pylori bacteria to clarithromycin-based therapies. The high rates of H. pylori resistance to clarithromycin have led to significant rates of treatment failure with clarithromycin-based therapies and are a strong public health concern, as highlighted by the ACG, FDA and the World Health Organization (WHO) in recent years.
Talicia® is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (PPI) (omeprazole). In November 2019, Talicia® was approved by the U.S. FDA for the treatment of H. pylori infection in adults. In the pivotal Phase 3 study, Talicia® demonstrated 84% eradication of H. pylori infection in the intent-to-treat (ITT) group vs. 58% in the active comparator arm (p<0.0001). Minimal to zero resistance to rifabutin, a key component of Talicia®, was detected in RedHill's pivotal Phase 3 study. Further, in an analysis of data from this study, it was observed that subjects who were confirmed adherent[4] to their therapy had response rates of 90.3% in the Talicia® arm vs. 64.7% in the active comparator arm[5].
Talicia® is eligible for a total of eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide.
About H. pylori
H. pylori is a bacterial infection that affects approximately 35%[6] of the U.S. population, with an estimated two million patients treated annually[7]. Worldwide, more than 50% of the population has
H. pylori infection, which is classified by the WHO as a Group 1 carcinogen. It remains the strongest known risk factor for gastric cancer[8] and a major risk factor for peptic ulcer disease[9] and gastric mucosa-associated lymphoid tissue (MALT) lymphoma[10]. More than 27,000 Americans are diagnosed with gastric cancer annually[11]. Eradication of H. pylori is becoming increasingly difficult, with current therapies failing in approximately 25-40% of patients who remain H. pylori-positive due to high resistance of H. pylori to antibiotics - especially clarithromycin - which is still commonly used in standard combination therapies[12].
As for RedHill, the insiders' purchases amounted to well under 1% of the biotech's outstanding shares. So why did the stock price jump so much? Investors love to see insider buying. It reinforces the impression that a company's board and executives are confident about the business's prospects.
RedHill plans to soon talk with regulators, including the FDA, about the next steps for its experimental COVID-19 pill, opaganib. Earlier this month, the company reported a statistically significant 62% reduction in mortality for the therapy among hospitalized patients with severe COVID-19 pneumonia.
https://www.fool.com/investing/2021/10/22/why-biontech-and-redhill-are-soaring-this-week-whi/?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article
PEOPLE-THE-PILL-WORKS!!!!-62%-BETTER-CHANCE-TO-LIVE-MRK-PILL-IS-50%.
There is no hype and they do not have a partner so no clout to have same exposure as MRK
RedHill Biopharma to Present at the BIO-Europe 2021 Conference
Wed, October 20, 2021, 2:00 PM
https://finance.yahoo.com/news/redhill-biopharma-present-bio-europe-110000365.html
TEL AVIV, Israel and RALEIGH, N.C. , Oct. 20, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Mr. Adi Frish, RedHill's Chief Corporate & Business Development Officer, will present a corporate overview at the BIO-Europe Digital Conference, taking place October 25-28, 2021.
The presentation will be available on-demand for 30 days on the Company's website from the start of the conference: https://www.redhillbio.com/investors.
Whoa...presently up 20%...
"...a small, Israeli/U.S. upstart, RedHill Biopharma Ltd. (NASDAQ:RDHL), has quietly raced to the front of the pack for a novel COVID pill with its two-pronged oral development program..."
Thanks for the info midastouch!
David v Goliath in The Race to Develop an Oral Therapy for COVID-19
Broad agreement in the world of science can be a rarity. However, one thing that public health leaders active in the fight against COVID-19 can agree on, is the urgent need for oral, pill-based treatments that are effective at halting disease progression, can get — and keep — people out of the hospital and can reduce mortality. One key group of COVID-19 patients who are in desperate need of treatment options are those moderately severe patients in hospital who are at high risk of becoming critically ill, and for whom most drugs have so far failed to deliver.
A slew of promising drug candidates from big pharma such as Merck & Co. Inc. (NYSE:MRK), Roche Holdings AG (OTC:RHHBY), and Pfizer Inc. (NYSE:PFE) have so far either tried, and failed, to benefit this key majority group of hospitalized patients or are focused on managing much milder disease, in the outpatient setting, limited to within a few days from infection.
However, a small, Israeli/U.S. upstart, RedHill Biopharma Ltd. (NASDAQ:RDHL), has quietly raced to the front of the pack for a novel COVID pill with its two-pronged oral development program - one of which, opaganib, has just posted late-stage clinical data showing impressive mortality reduction figures in the underserved hospitalized patient population with moderately severe COVID-19.
RedHill believes this new data for its oral COVID-19 pill, opaganib, puts it ahead of some of the pharma behemoths who have struggled to show a benefit in hospitalized patients, outside of the earliest stages of disease. Moreover, opaganib, a sphingosine kinase-2 (SK2) inhibitor with a dual antiviral and anti-inflammatory action that targets human enzymes in cells in the body rather than the virus itself, has also delivered pre-clinical data demonstrating potent antiviral inhibition of SARS-CoV-2 variants, including the Beta, Gamma and Delta.
RedHill has recently reported new data from a post-hoc analysis of 251 hospitalized moderately severe COVID-19 pneumonia patients from its opaganib global Phase 2/3 study showing that treatment with opaganib versus the placebo-controlled arm resulted in a 62% reduction in mortality (nominal p-value=0.019). The new data also showed a 21% efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (nominal p-value=0.033), and a median four day benefit to hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo; nominal p-value=0.0195). The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask).
RedHill believes that the new data makes oral opaganib a potential game-changer and, if approved, has the potential to save lives. RedHill is optimistic about opaganib for several reasons, including:
Easy to take, make and distribute oral pill formulation
A dual mechanism of action — antiviral and anti-inflammatory — acting on the viral cause and inflammatory effects of COVID-19
It inhibits a human host factor, not the virus itself, and has shown preclinically to be effective against variants including Beta, Gamma and Delta
Manufacturing scale-up capability and product stability data in place
Advanced clinical development with previous positive U.S. Phase 2 trial data and encouraging compassionate use in Israel and Switzerland
Good safety based on extensive database from additional oncology studies
RedHill promotes 3 U.S. Food and Drug Administration approved drugs with its experienced U.S. sales team and has built an advanced R&D pipeline of proprietary late-stage clinical development drug candidates.
For more information on RedHill Biopharmaceutical, go to www.redhillbio.com.
Disclaimer: This content has been provided pursuant to a commercial agreement under which RedHill Biopharma paid a fee to the publisher.
5.31+0.44 (+9.10%)
As of 11:31AM EDT. Market open.
Volume 1,068,836
Avg. Volume 997,649
Finally a positive price increase,
probably due to:
Atea Pharma's COVID-19 treatment fails to meet study goal; shares plunge
The company is developing the oral drug, AT-527, in partnership with
Roche (ROG.S) and both the companies are collaborating on multiple
studies of the drug for the treatment of COVID-19.
https://ih.advfn.com/p.php?pid=nmona&article=86316085
RedHill Biopharma Announces Insider Buying
https://finance.yahoo.com/news/redhill-biopharma-announces-insider-buying-110200802.html
TEL-AVIV, ISRAEL and RALEIGH, NC / ACCESSWIRE / October 18, 2021 / RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that members of its board of directors and senior management, including the Company's Chairman & CEO, CFO, Chief Commercial Officer, Chief Business Officer and Chief Corporate & Business Development Officer, collectively purchased approximately 180,000 American Depositary Shares (ADSs) of RedHill between mid-September and October 15, 2021 in open-market transactions.
A very frustrating situation,
ain't no doubt about it!
I'm hoping Redhill releases some bad news! Maybe that will raise the share price!!
RedHill Biopharma Announces New U.S. Patent Covering Talicia for H. pylori Infection Through 2034
https://finance.yahoo.com/news/redhill-biopharma-announces-u-patent-110000906.html
- The patent is directed to the Talicia® formulation and pharmaceutical kits for use in the treatment of H. pylori infection
- The new patent, valid through 2034, will be the fifth patent listed in the FDA Orange Book for Talicia
- Talicia is designed as a first-line option to address the high resistance of H. pylori bacteria to historical standard-of-care therapies
- H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population
TEL AVIV, Israel and RALEIGH, N.C., Oct. 12, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced the granting of U.S. Patent No. 11,135,172 covering Talicia, its U.S. approved medicine indicated for the treatment of H. pylori infection in adults. This patent reinforces the protection for Talicia through 2034, and the Company plans to list this patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
"Talicia's unique all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults. Once listed, we will have five Orange-Book listed patents protecting Talicia," said Danielle T. Abramson, PhD., SVP, Global Head of Intellectual Property. "We continue to build an expansive international patent portfolio to protect this innovative formulation, which addresses increasing concerns of resistance related to clarithromycin and metronidazole and which supports ease of adherence and compliance by patients, provides a favorable tolerability and safety profile and is positioned to become the new first-line standard-of-care."
RedHill Biopharma shares rise after new U.S. patent for H. pylori infection treatment Talicia
Oct. 12, 2021 7:40 AM ETRedHill Biopharma Ltd. (RDHL)
By: Aakash Babu, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) announces that the company has been granted a new U.S. patent covering Talicia, an approved medicine indicated for the treatment of H. pylori infection in adults.
The new patent reinforces the protection for Talicia through 2034, and the company plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book.
Talicia's all-in-one capsule comprising a proton pump inhibitor and two antibiotics was approved by the U.S. FDA in November 2019 for the treatment of H. pylori infection in adults.
These Are the Stocks to Watch as COVID-19 Enters Its Next Phase
https://time.com/6105697/stocks-covid-vaccines/
OCTOBER 9, 2021 12:54 PM EDT
The first pill to treat Covid-19 is on its way and vaccine producers are rolling out booster shots in wealthy countries. For investors, the next stage of the pandemic means a tougher landscape for stockpicking.
The success of Merck & Co.’s oral antiviral treatment in a clinical trial has shifted the momentum in the stock market, weighing on shares of the companies that developed the most effective vaccines, Moderna Inc. and the duo of Pfizer Inc. and BioNTech SE.
Nineteen months into the pandemic, a successful rollout of a Covid-19 pill could quicken and broaden the world’s recovery, opening up a plethora of investment opportunities in stock markets.
What a Tattered Pillow Taught Me About Grieving
Here are some stocks seen by traders as possible winners and losers:
Pill Makers
Dozens of companies around the globe have said they’re trying to do what Merck appears to have succeeded at: Develop an easily administered treatment that reduces the risk of serious illness or death for people infected with coronavirus. For most of them, the effort has come to nothing, and after brief share spikes, their stocks have fallen back.
Among the bigger companies still working on antivirals are Pfizer, Shionogi & Co. and Roche Holding AG with partner Atea Pharmaceuticals Inc. All plan to publish results from late-stage clinical trials by the end of the year. Shionogi’s pill could be a $2 billion drug, the Japanese company said Friday.
A tiny Israeli biotech, RedHill Biopharma Ltd., said Oct. 4 its experimental oral therapy showed promise in helping hospitalized patients. The study consisted of only 251 people; weeks earlier RedHill had said the drug failed to show an effect in a broader group of patients. The company is discussing next steps with regulators.
“The Covid pills are really a complement to the vaccines,” said Shane Oliver, head of investment strategy at AMP Capital Investors Ltd. in Sydney. They could reduce demand for costlier treatments such as intravenous medicines, he added.
Another tiny company, Synairgen Plc of the U.K., was one of the last year’s investor favorites, soaring 2,520% on optimism for its inhaled treatment for Covid-19. The stock has fallen 2% this year. It too expects late-stage trial data by year’s end.
Vaccines
The possible arrival of Merck’s molnupiravir pill, coupled with the prospect that the pandemic will wane further, already is weighing on the valuations of jab makers.
Moderna’s share price has almost tripled in 2021 after surging 434% last year. The stock’s inclusion in the S&P 500 in July further propelled it to a record and sent it soaring past analysts’ price targets.
Still, it’s now priced at 11 times estimated earnings, down from 147 times in July 2020. The recent selloff finally brought the stock back in line with analysts’ 12-month projections for the first time in more than four months.
The share price of Pfizer’s German partner BioNTech is even cheaper at 5.9 times earnings, despite tripling this year.
“Vaccines remain the primary prevention measure and largest market opportunity,” Morgan Stanley analyst Matthew Harrison wrote in a note dated Oct. 5.
Still, it’s unclear how big that market will be: Harrison’s forecast for annual coronavirus vaccine sales over the long term ranges from $3 billion to $30 billion. He has equal-weight ratings on Pfizer and Moderna.
The vaccine leaders may also lose market share if new inoculations from Sanofi, Novavax Inc. or Valneva SE succeed and if mix-and-match boosting appears to be effective. The U.S. FDA is reviewing results of a study of adults who received booster doses of different vaccines than their original shots.
Pfizer and BioNTech are seeking U.S. approval for use of their shots on children ages 5-11, while Moderna is testing its shot in kids as well.
In Asia, watch firms such as Shanghai Fosun Pharmaceutical Group Co., which has a deal to distribute BioNTech and Pfizer’s vaccine in greater China, and South Korea’s SK Bioscience Co., a local production partner for AstraZeneca Plc.
Intravenous Treatments
The convenience of a pill for Covid could take market share from expensive infusions that need to be done in a clinic, namely the monoclonal antibody treatments from Eli Lilly & Co., Regeneron Pharmaceuticals Inc., Gilead Sciences Inc., GlaxoSmithKline Plc and partner Vir Biotechnology Inc.
New oral antivirals “could open up a broader population to Covid-19 treatments in a true outpatient setting,” wrote Goldman Sachs Group Inc. analyst Chris Shibutani in an Oct. 1 research note.
Covid Testing
The continuing vaccination and a possible therapeutic may also curb the need for Covid testing kits.
“Less hospitalizations as a result of Covid (which will surely be aided by molnupiravir and similar treatments) will result in a dialed-back pandemic response, which should then result in less demand for asymptomatic testing — especially for rapid testing,” said Tycho Peterson, an analyst at JPMorgan Chase & Co.
Goldman analysts are more pessimistic, saying the market for rapid Covid tests will “collapse” in 2022 to less than $200 million outside of symptomatic and PCR testing. Companies making those quick diagnostics, known as antigen tests, namely Qiagen NV, DiaSorin SpA and Abbott Laboratories, have all slumped from their recent peaks in September.
Quidel Corp., Orasure Technologies Inc. and Abbott will be in focus in the U.S. Sugentech Inc., Biolidics Ltd., Metropolis Heathcare Ltd., Thyrocare Technologies Ltd. and Dr Lal PathLabs Ltd. are on traders’ radar in Asia.
Other stocks to watch include lab operator Eurofins Scientific SE and suppliers of lab equipment such as Fluidigm Corp., Sartorius AG, Sartorius Stedim Biotech and Tecan Group AG.
–With assistance from Morwenna Coniam and Michael Msika.
A rush to buy Covid pills
At least four countries in the Asia-Pacific region announced agreements with the drug maker Merck to purchase a pill that the pharmaceutical company says could halve the risk of hospitalization and death from Covid-19.
Australia, Malaysia, Singapore and South Korea have all announced agreements to buy supplies of molnupiravir, the Covid treatment pill, even though their regulatory agencies have yet to approve the drug. Thailand and Taiwan are also reported to be in talks to purchase supplies of the pill.
The announcements came less than a week after the pill’s manufacturer released results from clinical trials that showed its effectiveness. The countries are the first to agree to buy the pill other than the U.S., which purchased enough pills for 1.7 million treatments for $1.2 billion in June.
Treatment: Merck’s pill, the first oral antiviral drug that can be taken at home, is expected to help limit future coronavirus outbreaks and to reduce the need for costly hospital stays.
Redhill says EUA (Emergency Use Authorization) for Covid therapeutic pill in process. Says results are better than Mercks.
5.09+0.40 (+8.45%)
As of 11:07AM EDT. Market open.
Going places (finally?)
Nice Nroadcast!
Great news! Why aren’t we much higher?
We invite you to join RedHill Biopharma (RDHL) tomorrow, October 7, 2021, at 8:30 a.m. EDT for a webcast during which we will present the additional analysis of the Phase 2/3 study results and answer questions.
The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.
Follow us on Twitter: @RedHillBio
Company contact:
Adi Frish
Chief Corporate & Business Development Officer
RedHill Biopharma
+972-54-6543-112
adi@redhillbio.com
RedHill Biopharma falls 4% amid H. pylori drug Talicia addition to California's Medi-Cal
Oct. 06, 2021 10:23 AM ETRedHill Biopharma Ltd. (RDHL)
By: Ravikash, SA News Editor1 Comment
RedHill Biopharma (RDHL -3.6%) said California's Medicaid Health Care program Medi-Cal added Talicia to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective Oct. 1.
"Medi-Cal's addition of Talicia with no prior authorization required is an important step in Talicia's continuing growth and we are pleased that it will be made available to Medi-Cal's 2 million FFS lives," said RedHill CFO Rick Scruggs.
"There is growing recognition of the need to employ effective, first-line therapy against H. pylori infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria," added Scruggs.
Hopefully some BP will take interest
with Opanagib and take it under their
'wings' in this or other manner in order
to further develop/commercialize the pill,
after all, the results so far looks quite
promising.
I am still optimistic that not all is lost
in the Opaganib front!
RedHill Biopharma's Talicia® added to Medi-Cal Contract Drug List with No Prior Authorization Requirements
https://finance.yahoo.com/news/redhill-biopharmas-talicia-added-medi-110000903.html
Addition of Talicia® by Medi-Cal Fee-For-Service (FFS) Contract Drug List (CDL) with no prior authorization is an important expansion of coverage for California patients and continues to increase Talicia's overall unrestricted coverage
Coverage commenced for two million patients in Medi-Cal's FFS plan on October 1st, 2021
Talicia® is the first and only FDA-approved rifabutin-based therapy for H. pylori infection, designed as a first-line option to address the high resistance of H. pylori bacteria to standard-of-care therapies
H. pylori bacterial infection is a Group 1 carcinogen and the strongest risk factor for gastric cancer; H. pylori affects approximately 35% of the U.S. population
TEL-AVIV, Israel and RALEIGH, N.C., Oct. 6, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia® (omeprazole magnesium, amoxicillin and rifabutin)[1] to its Contract Drug List (CDL) for H. pylori treatment, with no prior authorization required, effective October 1, 2021.
Coverage for Talicia commenced for two million patients in Medi-Cal's California FFS plan on October 1, 2021.
"Medi-Cal's addition of Talicia with no prior authorization required is an important step in Talicia's continuing growth and we are pleased that it will be made available to Medi-Cal's 2 million FFS lives," said Rick Scruggs, RedHill's Chief Commercial Officer. "There is growing recognition of the need to employ effective, first-line therapy against H. pylori infections that does not rely on clarithromycin and that patients can tolerate well and adhere to over 14 days of therapy. Talicia meets those criteria."
RDHL-ALSO-ONLY-10-DAYS-OUT-OF-HOSPITAL-COMPARED-TO-14 DAYS
RDHL-ALSO-ONLY-10-DAYS-OUT-OF-HOSPITAL-COMPARED-TO-14 DAYS
MRK-ONLY-50%-AND-IT-WAS-ALL-OVER-THE-NEWS-RDHL-62%-DECREASE-IN-DEATHS-MODERATE-SEVERE-COVID.
Why RedHill Biopharma Blasted 12% Higher Today
The company's Opaganib might have a promising future, after all.
https://finance.yahoo.com/m/56c0d9ef-2986-389d-855c-7f11353c6eed/why-redhill-biopharma-blasted.html?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo
Eric Volkman
(TMFVolkman)
Oct 4, 2021 at 5:46PM
Author Bio
What happened
RedHill Biopharma (NASDAQ:RDHL) was a standout stock on a gloomy Monday for the market. The biotech's shares rose by just under 12% on positive and not entirely expected news about its top pipeline drug.
So what
Monday morning, RedHill announced that its opaganib produced a 62% statistically significant reduction in mortality in hospitalized individuals with severe COVID-19 pneumonia. This was according to new data from a global phase 2/3 study.
This surprised more than a few investors and observers of the biotech, as preliminary top-line data released from the study last month wasn't nearly as heartening. That data showed that opaganib didn't meet its primary endpoint of having a sufficient number of patients breathing without being administered oxygen.
Opaganib is an oral medication currently being studied for a number of indications. Besides COVID-19 pneumonia, it could potentially be used to treat certain cancers, in addition to inflammatory and gastrointestinal difficulties.
"These new findings support the potential for opaganib's use in hospitalized, moderately severe COVID-19 patients -- a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib's combined antiviral and anti-inflammatory activities," RedHill quoted its medical director Mark Levitt as saying.
Now what
While there's still much investigational work to be done with opaganib, this fresh news is quite encouraging -- particularly considering that the delta variant is still wreaking havoc on the world's collective health.
RedHill clearly sees much potential in its pipeline drug. Levitt added that, "We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease."
RedHill Biopharma says its oral COVID-19 therapy cut risk of death by 62% in study
Oct. 04, 2021 8:34 AM ETRedHill Biopharma Ltd. (RDHL)Veeva Systems Inc. (VEEV)
By: Dulan Lokuwithana, SA News Editor
RedHill Biopharma (NASDAQ:RDHL) is trading ~6.2% higher in the pre-market after the company said that in a Phase 2/3 study, its experimental oral COVID-19 therapy opaganib compared to placebo led to a 62% decline in mortality in hospitalized patients with severe COVID-19 pneumonia.
Per the new data disclosed from an analysis of 251 patients, there were seven deaths among 117 patients who received opaganib compared to 21 deaths in the placebo arm consisting of 134 patients indicating a statistical significance of the result with a nominal p-value of 0.019.
Meanwhile, 77% of opaganib-treated patients reached room air by Day 14 compared to 63.5% for placebo (nominal p-value= 0.033).
In addition, those who were treated with opaganib left the hospital early with a median time to discharge of 10 days compared to 14 days for the placebo arm (nominal p-value=0.0195).
The overall adverse events were balanced between the two groups of the study, and no new safety signals were found, the company said.
A conference call is scheduled for Oct. 07 at 8:30 a.m. EDT to present additional data from the Phase 2/3 study.
Veeva Systems (NYSE:VEEV) and Bioforum have partnered with RedHill Biopharma (RDHL) for a global Phase 2/3 study designed to evaluate opaganib in patients hospitalized with severe COVID-19 pneumonia.
RedHill Biopharma Reports Further Analysis of Phase 2/3 Data Including a 62% Reduction in Mortality with Oral Opaganib in Moderately Severe COVID-19 Patients
https://finance.yahoo.com/news/redhill-biopharma-reports-further-analysis-120000369.html
62% statistically significant reduction in mortality shown for moderately severe COVID-19 patients group treated with opaganib vs. the placebo-controlled arm (7 deaths in the 117-patient opaganib arm vs. 21 deaths in the 134-patient placebo arm; nominal p-value=0.019)
21% statistically significant efficacy benefit with opaganib in reaching room air by Day 14, the study primary endpoint (77% of opaganib patients vs 63.5% on placebo; nominal p-value=0.033)
A median four days earlier hospital discharge for opaganib-treated patients vs. placebo (10 days for opaganib arm vs. 14 days for placebo) a cumulative saving of 524 days of hospitalization across the group by Day 42 (nominal p-value=0.0195)
The moderately severe group comprised 53% of study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline (inhaled supplemental oxygen via nasal cannula or face mask)
Data indicates a potential meaningful benefit with opaganib for these hospitalized, moderately severe COVID-19 patients - a group at high risk of disease progression, morbidity and mortality; the data also supports opaganib's potential use in earlier stages of COVID-19 disease, consistent with opaganib's U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants
RedHill will hold a webcast on Thursday, October 7, 2021, at 08:30 am EDT to further discuss these additional analyses
TEL AVIV, Israel and RALEIGH, N.C., Oct. 4, 2021 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported new data from the opaganib global Phase 2/3 study in hospitalized patients with severe COVID-19 pneumonia showing that treatment with oral opaganib (ABC294640)[1] vs. the placebo-controlled arm resulted in a 62% statistically significant reduction in mortality as well as statistically significant improved outcomes in time to room air and median time to hospital discharge in a group of 251 hospitalized, moderately severe COVID-19 patients, comprising 53% of the 475 study participants.
These important new results are from a post-hoc analysis of data from the 251 study participants requiring a Fraction of inspired Oxygen (FiO2) up to 60% at baseline. Patients with FiO2 ≤ 60% are still considered to be severely affected and typically require oxygen supplementation via a nasal cannula or face mask.
"These new findings support the potential for opaganib's use in hospitalized, moderately severe COVID-19 patients - a key group of patients that are at high risk of disease progression, morbidity and mortality, and who may benefit from opaganib's combined antiviral and anti-inflammatory activities," said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. "The results provide a strong rationale for opaganib's potential efficacy in hospitalized patients in need of oxygen supplementation up to 60% FiO2, a large proportion of hospitalized COVID-19 patients. The Phase 2/3 study results are also consistent with opaganib's earlier U.S Phase 2 study results and the demonstrated potent antiviral inhibition of SARS-CoV-2 variants in human bronchial epithelial cells, providing further support for its potential in earlier stages of disease where viral load is higher."
"We are excited about this promising and robust dataset. We are not aware of any other novel oral pill-based therapy that has shown a similar magnitude of difference in the mortality outcomes of hospitalized patients who are at this moderately severe stage of disease. The data indicates opaganib's potential to provide an effective option, in an easy to take and distribute pill-form, to help prevent patient deterioration and mortality," said Dror Ben-Asher, RedHill's CEO. "Pinpointing the most relevant target patient population is particularly challenging with novel drugs, novel mechanisms of action and a previously unknown disease. This trial and these data have given us a clear indication of which groups of patients are likely to benefit the most from opaganib."
Analyses of the FiO2 up to 60% patient subset from the opaganib Phase 2/3 study (n=251), the approximate median for FiO2 levels in the study, who were treated with either opaganib or placebo in addition to standard-of-care (including dexamethasone and/or remdesivir) demonstrate consistent benefit across endpoints, in this subset of hospitalized moderately severe patients. Given the post-hoc characteristics of this subset, statistical inferences of significance cannot be formally attributed (nominal values presented). The Company also conducted a Sensitivity Analysis to account for missing data interpretability[2]:
Mortality: Opaganib treatment resulted in a statistically significant 62% reduction in mortality (7/117 patients treated with opaganib vs. 21/134 for placebo; nominal p-value=0.019, Relative Risk 2.6) (Sensitivity Analysis: 5/117 vs. 16/134, 64% efficacy benefit; nominal p-value=0.033, Relative Risk - 2.8).
A detailed analysis of baseline risk factors and their potential impact on the mortality outcome in the sensitivity analysis group has also been undertaken, showing that the benefit is robustly maintained irrespective of the subgroups/risk factors, confirming that the positive outcome observed is due to opaganib.
Reaching Room Air by Day 14 (primary endpoint of the study): 77% of opaganib-treated patients reached room air by Day 14 vs. 63.5% for placebo – an efficacy benefit of 21% with opaganib (nominal p-value= 0.033).
Median time to discharge: Patients treated with opaganib showed median time of 10 days to discharge vs. 14 days for the placebo arm, resulting in a saving of four days hospitalization per opaganib patient and saving a total of 524 cumulative days of hospitalization across the group by Day 42, nominal p-value=0.0195
Safety: Overall adverse events were balanced between the opaganib and placebo groups, suggesting good safety, with no new safety signals emerging, further supporting potential use in this patient population and earlier stage populations. [3]
The multi-center, randomized, double-blind, parallel-arm, placebo-controlled global Phase 2/3 study enrolled 475 subjects with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects were randomized at a 1:1 ratio to receive either opaganib or placebo, on top of standard-of-care therapy.
The new data of the sub-group analysis follows the Company's previously announced top-line results of the Phase 2/3 study. Analysis of the top-line data is still ongoing, including further analysis of the potential for increased benefit of treatment with opaganib in patients at earlier stages of disease. RedHill intends to discuss the study outcomes with regulators, including U.S. FDA and U.S. government agencies, as well as other regulators and governments and international agencies, to help determine next steps.
Opaganib is a novel small molecule investigational drug in oral pill form. Opaganib has a unique dual antiviral and anti-inflammatory mechanism of action that acts on the viral cause and inflammatory effect of COVID-19. It is believed to exert its antiviral effect by selectively inhibiting SK2, a key enzyme produced in human cells that may be recruited by the virus to support its replication and is expected to be effective against emerging viral variants, having already preclinically demonstrated strong inhibition against variants of concern, including Delta.
Webcast and Conference Call Information:
The Company will host a webcast on Thursday, October 7, 2021, at 8:30 a.m. EDT, during which it will present the additional analysis of the Phase 2/3 study results and answer questions.
The webcast including slides will be broadcast live on the Company's website, https://www.redhillbio.com/investors/events-and-presentations/default.aspx, and will be available for replay for 30 days.
To participate in the conference call, please dial one of the following numbers 15 minutes prior to the start of the call: United States: +1-877-870-9135; International: +1 646-741-3167 and Israel: +972-3-530-8845; the access code for the call is: 4785122.
About Opaganib (ABC294640)
Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity. Opaganib is host-targeted and is expected to be effective against emerging viral variants, having already demonstrated strong inhibition against variants of concern, including Delta. Opaganib has also shown anticancer activity and positive preclinical results in renal fibrosis, and also has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.
Opaganib previously delivered positive U.S. Phase 2 data in patients with severe COVID-19, submitted for peer review and recently published in medRxiv.
Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer. Based on a preliminary review of partial unaudited data, the ongoing study in prostate cancer has met its primary endpoint. Patient accrual, treatment and analysis in this study are ongoing.
Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, inhibiting viral replication of all SARS-CoV-2 variants tested to date in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib's potential to ameliorate inflammatory lung disorders, such as pneumonia, have demonstrated opaganib's potential to decrease renal fibrosis and have shown decreased fatality rates from influenza virus infection and amelioration of Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[4].
The ongoing clinical studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.
The top-line results from the Company's Phase 2/3 study with opaganib are preliminary in nature. The Company intends to further examine the data from this study in greater detail, along with all the information gathered during this study, including all safety, and secondary outcome measures. Such analysis may result in findings which are new or inconsistent with the top-line data disclosed in this release. As such, investors should not rely on the analyses reported in this release as the final definitive results of the study.
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Moderators midastouch017 |
NCI
BARDA
U.S. Department of Defense
FDA Office of Orphan Products Development
Top-line data from the 270-patient global Phase 2/3 COVID-19 study expected Q1/2021
Top-line data from the 40-patient U.S. Phase 2 study of opaganib in severe COVID-19 expected in the coming days; this non-powered study was designed to evaluate safety and potential identification of preliminary efficacy signals in support of the global Phase 2/3 study of opaganib
(Posted 12/22/2020)
21 Ha'arba'a Street
Tel Aviv 6473921
Israel
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http://www.redhillbio.com
[1] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=1358&PID=0&IID=1899
[2] https://www.redhillbio.com/RedHill/Templates/showpage.asp?DBID=1&LNGID=1&TMID=178&FID=2432&PID=0&IID=17299
PER IHUB MGMT |
02-07-2021
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